Association between social integration and loneliness among the female migrant older adults with children: the mediating effect of social support.

BACKGROUND: The number of migrant older adults with children (MOAC) in China has been increasing in recent years, and most of them are women. This study aimed to explore the mediating effect of social support between social integration and loneliness among the female MOAC in Jinan, China. METHODS: In this study, 418 female MOAC were selected using multi-stage cluster random sampling in Jinan, Shandong Province, China. Loneliness was measured by the eight-item version of the University of California Los Angeles Loneliness Scale (ULS-8), and social support was measured by The Social Support Rating Scale (SSRS). Descriptive analyses, t-tests, ANOVA, and structural equation modeling (SEM) were used to illustrate the relationship between social integration, social support, and loneliness. RESULTS: The average scores of ULS-8 and SSRS were 12.9 ± 4.0 and 39.4 ± 5.9 among female MOAC in this study. Social integration and social support were found to be negatively related to loneliness, and the standardized direct effect was -0.20 [95% CI: -0.343 to -0.068] and -0.39 [95% CI: -0.230 to -0.033], respectively. Social support mediated the relationship between social integration and loneliness, and the indirect effect was -0.16 [95% CI: -0.252 to -0.100]. CONCLUSION: The female MOAC's loneliness was at a relatively lower level in this study. It was found that social integration was negatively associated with loneliness, and social support mediated the relationship between them. Helping female MOAC integrate into the inflow city and improving their social support could be beneficial for alleviating their loneliness.

Sensory impairment, loneliness, and the discordance between subjective and objective cognitive function among older adults: A multi-cohort study.

OBJECTIVES: This study aimed to examine the association between sensory impairment and the discordance between subjective/objective cognitive function among older adults and test the mediating effect of loneliness. METHODS: We used data from four cohort studies conducted in 16 countries (N = 19,119). Sensory impairment and subjective cognitive impairment were self-reported. Objective cognitive impairment was measured in three dimensions. Generalized estimating equations were conducted to examine the association between sensory impairment and discordance in subjective/objective cognitive function. Cross-lagged panel model and a bootstrap method with 2,000 samples were employed to verify the mediating effect. RESULTS: Sensory impairment was related to an increased risk of subjective cognitive impairment (OR = 4.70, 95 % CI 4.33-5.10), objective impairment (OR = 1.51, 95 %CI 1.31-1.74), as well as the discordance in subjective/objective cognitive function (OR = 1.35, 95 %CI 1.06-1.71 for older adults with normal subjective cognitive function). In contrast, sensory impairment was associated with a decreased risk of discordant subjective/objective cognitive function among those with subjective cognitive impairment (OR = 0.79, 95 %CI 0.66-0.94). Moreover, loneliness mediated the association between sensory impairment and subjective cognitive impairment (standardized indirect effect = 0.002, 95 %CI 0.001-0.004), objective cognitive impairment (standardized indirect effect = 0.005, 95 %CI 0.003-0.007) as well as the discordance in subjective/objective cognitive function (standardized indirect effect = 0.001, 95 %CI 0.001-0.003 for older adults with normal subjective cognitive function). CONCLUSIONS: Significant association between sensory impairment and discordance in subjective/objective cognitive function and the mediating role of loneliness were revealed, varying by subjective cognitive function. Early screening on sensory impairment and targeted interventions on loneliness should be considered in future policies on cognitive impairment.

Pharmacokinetics and safety of a new generic lurasidone: a phase I bioequivalence study in healthy Chinese subjects.

Latuda® is a novel antipsychotic drug for schizophrenia and bipolar depression. A bioequivalence trial was performed to investigate the bioequivalence of Latuda® and its generic drug lurasidone. Two independent trials were carried out, each involving 28 subjects. In the fasting trial, subjects were randomly assigned to two groups (1:1 ratio), receiving either 40 mg of generic lurasidone or Latuda®. After a 7-day washout period, subjects entered the second period with a crossover administration of 40 mg of generic lurasidone or Latuda®. The postprandial study design was similar to that of the fasting study. In the fasting study, the pharmacokinetic (PK) parameter values of generic lurasidone and Latuda® were as follows: the Cmax was 28.84 ± 19.34 ng/ml and 28.22 ± 21.19 ng/ml, respectively; the AUC0-t was 121.39 ± 58.47 h*ng/ml and 118.35 ± 52.24 h*ng/ml, respectively; and the AUC0-∞ was 129.63 ± 63.26 h*ng/ml and 126.59 ± 57.99 h*ng/ml, respectively. The primary pharmacokinetic parameter, Cmax, was assessed for equivalence using reference-scaled average bioequivalence (RSABE), while other parameters (AUC0-t, AUC0-∞) were evaluated using average bioequivalence (ABE). The results indicate that both Cmax and AUC meet the equivalence criteria. In the postprandial study, the PK values of generic lurasidone and Latuda® were as follows: the Cmax was 74.89 ± 32.06 ng/ml and 83.51 ± 33.52 ng/ml, respectively; the AUC0-t was 274.77 ± 103.05 h*ng/ml and 289.26 ± 95.25 h*ng/ml, respectively; and the AUC0-∞ was 302.44 ± 121.60 h*ng/ml and 316.32 ± 109.04 h*ng/ml, respectively. The primary pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞) were assessed for equivalence using ABE, and both met the equivalence criteria. In the study, lurasidone and Latuda® both exhibited acceptable safety and tolerability. The results displayed that lurasidone and Latuda® were bioequivalent and safe in healthy Chinese participants. Clinical Trial Registry: This trial is registered at chinadrugtrials.org.cn (no.: CTR20191717, date: 2019.08.29).

The chain mediation model of social support and life satisfaction among migrant older adults with children: The role of mental health and sleep quality.

INTRODUCTION: Few studies have examined the life satisfaction of migrant older adults with children (MOAC), who emerged due to rapid urbanization and population aging in China. This study aimed to explore the chain mediating effect of mental health and sleep quality on the association between social support and life satisfaction among MOAC in Weifang, China. METHODS: A cross-sectional study was conducted using multi-stage cluster random sampling, and 613 participants were included. The Social Support Rating Scale, Depression Anxiety Stress Scale, Pittsburgh Sleep Quality Index, and Scale with Life Satisfaction were used to measure the social support, mental health, sleep quality, and life satisfaction of MOAC, respectively. Descriptive statistics, t-tests, and ANOVA were used to explore the relationship between sociodemographic variables and life satisfaction. Pearson's correlation analysis and structural equation modeling (SEM) were conducted to investigate the association between social support, mental health, sleep quality, and life satisfaction. RESULTS: The mean total SWLS score was 27.87±5.58. SEM analysis demonstrated that social support had a positive effect on life satisfaction (ß= 0.197). Mental health and sleep quality partially mediated the association between social support and life satisfaction (95% CI: 0.083-0.193), and the mediating effect accounted for 39.198% of the total effect. CONCLUSION: Life satisfaction was relatively high, and mental health and sleep quality partially mediated the association between social support and life satisfaction. Policy suggestions were provided based on these results.

Association between self-reported oral health and cognitive function among the community-dwelling elderly in Jinan, China: the mediating effect of life satisfaction.

Background: Deterioration of self-reported oral health and decline in cognitive function are two main adverse health outcomes experienced by the older adults. Little evidence was found on the psychosocial mechanism between self-reported oral health and cognitive function. This study explores the association between self-reported oral health and cognitive function and examines the mediating effect of life satisfaction among the community-dwelling elderly in Jinan, China. Methods: A total of 512 older individuals (60+) were included in the study. Cognitive function was assessed using the Chinese version of the Mini-Mental State Examination scale (MMSE), and self-reported oral health was measured using the Chinese version of the Geriatric Oral Health Assessment Index (GOHAI). Pearson correlation analysis was used to determine the relationship between self-reported oral health, life satisfaction, and cognitive function. Multivariate linear regression analysis was conducted to explore the possible effect of covariates. Structural equation modelling and Bootstrap analyses were conducted to verify the mediating role of life satisfaction. Results: The mean MMSE score was 25.65 ± 4.42. Better self-reported oral health was significantly associated with a higher level of life satisfaction, and those with higher life satisfaction experienced better cognitive function. Age, educational level and source of living expenses were found to be cofounding variables. Life satisfaction partially mediated the effect of self-reported oral health on cognitive function (95% confidence interval [CI]: 0.010 to 0.075). The mediating effect of life satisfaction accounted for 24% of the total effect. Conclusion: The level of cognitive function was relatively high. Self-reported oral health was positively associated with cognitive function, and the mediating effect of life satisfaction was proven to exist in the community-dwelling older individuals. Early screening for oral diseases and a greater focus on life satisfaction are recommended.

Pharmacokinetics and bioequivalence of sunitinib and Sutent® in Chinese healthy subjects: an open-label, randomized, crossover study.

Purpose: The purpose of this study was to examine the pharmacokinetics (PK), bioequivalence and safety of generic sunitinib and its original product Sutent® in healthy Chinese subjects through a phase-I clinical trial. Methods: The study selected two groups of 24 healthy Chinese subjects in a 1:1 ratio through random allocation. Each participant received either 12.5 mg of sunitinib or Sutent® per cycle. A total of 15 different time points were employed for blood sample collection during each cycle. Furthermore, a comprehensive assessment of the drugs' safety was consistently maintained throughout the trial. Results: The average adjusted geometric mean ratios (GMR) (90% CI) for the primary PK parameters Cmax, AUC0-t and AUC0-∞ were 97.04% (93.06%-101.19%), 98.45% (93.27%-103.91%) and 98.22% (93.15%-103.56%), respectively. The adjusted GMRs for essential pharmacokinetic (PK) parameters all met the requirements for bioequivalence, with values within the acceptable range of 80%-125%. In addition, the two drugs showed comparable results for the other PK parameters. These results indicate that the two drugs were bioequivalent. Furthermore, both drugs showed well safety. Conclusion: The research results proved that the PK and safety profiles of sunitinib in healthy Chinese subjects were comparable to those of Sutent®. These results advocate the clinical application of generic sunitinib as a potential alternative to original product Sutent® in the treatment of certain medical conditions.

Pharmacokinetics and safety of dasatinib and its generic: a phase I bioequivalence study in healthy Chinese subjects.

BACKGROUND: Dasatinib (Sprycel®) is a tyrosine kinase inhibitor for treating chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. RESEARCH DESIGN & METHODS: We designed a clinical study to demonstrate that the dasatinib tablet (YiNiShu®) (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) and Dasatinib (Bristol Myers Squibb) were bioequivalent under fasting and fed conditions. The whole study was structured into the fasting trial and the postprandial trial. Each period, subjects were given 50 mg dasatinib or its generic. The RSABE (reference scale average bioequivalence) and ABE (average bioequivalence) methods were employed to assess bioequivalence by pharmacokinetics (PK) parameters for a highly variable drug. RESULTS: 32 and 24 eligible volunteers were enrolled in the fasting and postprandial trials, respectively. In the fasting trial, the RSABE method was performed, and point estimates of Cmax, AUC0-t, and AUC0-∞ met the bioequivalence criteria. In the postprandial trial, the ABE method was performed, and the 90% CI of the geometric mean ratio (GMR) for PK parameters met the requirements of bioequivalence standards. CONCLUSION: The results proved that the PK parameters of the two drugs were similar and bioequivalent, indicating that both drugs had a good safety profile. CLINICAL TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov (Number: NCT05640804) and Drug Clinical Trial Registration and Information Disclosure Platform (Number: CTR20181708).

The protective effects of baicalin for respiratory diseases: an update and future perspectives.

Background: Respiratory diseases are common and frequent diseases. Due to the high pathogenicity and side effects of respiratory diseases, the discovery of new strategies for drug treatment is a hot area of research. Scutellaria baicalensis Georgi (SBG) has been used as a medicinal herb in China for over 2000 years. Baicalin (BA) is a flavonoid active ingredient extracted from SBG that BA has been found to exert various pharmacological effects against respiratory diseases. However, there is no comprehensive review of the mechanism of the effects of BA in treating respiratory diseases. This review aims to summarize the current pharmacokinetics of BA, baicalin-loaded nano-delivery system, and its molecular mechanisms and therapeutical effects for treating respiratory diseases. Method: This review reviewed databases such as PubMed, NCBI, and Web of Science from their inception to 13 December 2022, in which literature was related to "baicalin", "Scutellaria baicalensis Georgi", "COVID-19", "acute lung injury", "pulmonary arterial hypertension", "asthma", "chronic obstructive pulmonary disease", "pulmonary fibrosis", "lung cancer", "pharmacokinetics", "liposomes", "nano-emulsions", "micelles", "phospholipid complexes", "solid dispersions", "inclusion complexes", and other terms. Result: The pharmacokinetics of BA involves mainly gastrointestinal hydrolysis, the enteroglycoside cycle, multiple metabolic pathways, and excretion in bile and urine. Due to the poor bioavailability and solubility of BA, liposomes, nano-emulsions, micelles, phospholipid complexes, solid dispersions, and inclusion complexes of BA have been developed to improve its bioavailability, lung targeting, and solubility. BA exerts potent effects mainly by mediating upstream oxidative stress, inflammation, apoptosis, and immune response pathways. It regulates are the NF-κB, PI3K/AKT, TGF-ß/Smad, Nrf2/HO-1, and ERK/GSK3ß pathways. Conclusion: This review presents comprehensive information on BA about pharmacokinetics, baicalin-loaded nano-delivery system, and its therapeutic effects and potential pharmacological mechanisms in respiratory diseases. The available studies suggest that BA has excellent possible treatment of respiratory diseases and is worthy of further investigation and development.

A randomized, open-label, two-cycle, two-crossover phase I clinical trial comparing the bioequivalence and safety of afatinib and Giotrif® in healthy Chinese subjects.

OBJECTIVE: Afatinib is an oral, irreversible ErbB family blocker. It binds covalently to the kinase domains of epidermal growth factor (EGFR), HER2 and HER4, resulting in irreversible inhibition of tyrosine kinase autophosphorylation. Our trial compared the bioequivalence and safety between afatinib produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Giotrif® produced by Boehringer Ingelheim. METHODS: Healthy Chinese subjects (N = 36) were randomly divided into two groups at a ratio of 1:1. There was a single dose per period of afatinib and Giotrif®. The washout was set as 14 days. Plasma drug concentrations of afatinib and Giotrif® were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Statistical analysis of major pharmacokinetic (PK) parameters was conducted to assess drug bioequivalence. In addition, we evaluated the safety of the drugs throughout the trial. RESULTS: The geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ for afatinib and Giotrif® were 102.80%, 101.83%, and 101.58%, respectively. The 90% confidence intervals (CIs) were all within 80%-125%, meeting the bioequivalence standards. In addition, both drugs showed a good safety profile during the trial. CONCLUSION: This study showed that afatinib was bioequivalent to Giotrif® in healthy Chinese subjects with well safety. CHINESE CLINICAL TRIAL REGISTRY: This trial is registered at the Chinese Clinical Trial website ( http://www.chinadrugtrials.org.cn/index.html # CTR20171160).

Comparing the bioequivalence and safety of liraglutide in healthy Chinese subjects: an open, single-dose, randomized, repeated, two-sequence, two-cycle phase I clinical trial.

BACKGROUND: Glucagon-like peptide-1 (GLP-1) is an endogenous incretin hormone. Liraglutide, a GLP-1 receptor agonist, can lower blood sugar by increasing insulin production and inhibiting the production of glucagon. This study researched the bioequivalence and safety of the test and reference drugs in healthy Chinese subjects. RESEARCH DESIGN AND METHODS: Subjects (N = 28) were randomly divided into group A and group B at a ratio of 1:1 for a two-cycle cross-over study. There was single dose per cycle with subcutaneous injection of the test and reference drugs, respectively. The washout was set at 14 days. Plasma drug concentrations were detected by specific liquid chromatography and tandem mass spectrometry (LC-MS/MS) assays. Statistical analysis of major pharmacokinetic (PK) parameters was conducted to assess drug bioequivalence. In addition, we evaluated the safety of the drugs throughout the trial. RESULTS: The geometric mean ratios (GMRs) of Cmax, AUC0-t, and AUC0-∞ for the test and reference drugs were 107.11%, 106.56%, 106.09%, respectively. The 90% confidence intervals (CIs) were all within 80%-125%, meeting the bioequivalence standards. In addition, both had good safety in this study. CONCLUSION: The study shows that the two drugs had similar bioequivalence and safety. CLINICAL TRIAL REGISTRATION: DCTR: CTR20190914; ClinicalTrials.gov: NCT05029076.

Association between social support, smartphone usage and loneliness among the migrant elderly following children in Jinan, China: a cross-sectional study.

OBJECTIVES: As the fast population ageing in the past few decades, China has also witnessed an increase in the number of migrant elderly following children (MEFC). This study aims to examine the relationship between MEFC's social support, smartphone usage and loneliness in Jinan, China. DESIGN: Cross-sectional survey. SETTING: Shandong Province, China. PARTICIPANTS: The participants were 656 MEFC aged 60 years or above. PRIMARY AND SECONDARY OUTCOME MEASURES: Loneliness was measured by an eight-item version of the University of California Los Angeles Loneliness Scale (ULS-8). A t-test and one-way Analysis of Variance (ANOVA) were conducted to compare the level of loneliness across different sociodemographic variables, social support indicators and smartphone usage indicators. Structural equation modelling was used to validate the association between the above variables. RESULTS: The MEFC's mean score on the ULS-8 was 12.82±4.05, indicating a relatively lower level of loneliness. It was found that social support and smartphone usage exerted negative effects on loneliness of the MEFC, and the standardised direct effects were -0.165 (95% CI -0.257 to -0.070) and -0.094 (95% CI -0.180 to -0.003), respectively. Social support was found to be positively associated with smartphone usage of the MEFC, and the standardised direct effect was 0.147 (95% CI 0.052 to 0.246). CONCLUSIONS: The loneliness of the MEFC was relatively low and was clarified to be negatively associated with social support and smartphone usage. Effective intervention measures on social support and smartphone usage to alleviate loneliness among the MEFC in China were recommended based on this study.

The Relationship Between CDC Personnel Subjective Socioeconomic Status and Turnover Intention: A Combined Model of Moderation and Mediation.

A stable and motivated CDC workforce is critical for Chinese public health system improvement in the post-pandemic period of COVID-19. Meanwhile, the lack of career development prospects, low income, low status and the widespread and increasingly serious job burnout of employees CDC staff is a complex and difficult problem for the government. Therefore, this study explored the relationship between CDC personnel subjective socioeconomic status and turnover intention using a sample of 2,502 grass-roots CDC personnel who were administered with a subjective socioeconomic status scale, turnover intention scale, job burnout scale, and payment questionnaire. The results showed that: (1) subjective socioeconomic status had a significant association with job burnout and turnover intention; (2) all three dimensions of job burnout played a mediating role in the relationship between subjective socioeconomic status and turnover intention; (3) expected salary change played a moderating role between subjective socioeconomic status and turnover intention. The effect was stronger for workers with low expected salary change, which means due to the multidimensional comparative and complex mechanism of salary change, which had limited effect on turnover intention. These findings provide a basis for the relationship between turnover intention and socioeconomic status of grass-roots CDC personnel, and also provide ideas for reducing job burnout and staff turnover.

Association between Sense of Belonging and Loneliness among the Migrant Elderly Following Children in Jinan, Shandong Province, China: The Moderating Effect of Migration Pattern.

BACKGROUND: Driven by accelerating population aging and migration, the number of older migrants has increased rapidly in China. Those who moved to cities to look after grandchildren were referred to as the migrant elderly following children (MEFC). This study aims to examine the relationship between sense of belonging and loneliness and explore the moderating effect of migration pattern among the MEFC in China. METHODS: The study included 656 MEFC aged 60 years and above. Loneliness was evaluated by the eight-item University of California Los Angeles Loneliness Scale (ULS-8). Sense of belonging and migration pattern were measured using a self-designed questionnaire. Hierarchical multiple regression was conducted to test the proposed association and moderating effect. A margins plot was introduced to illustrate this effect. RESULTS: The average ULS-8 score was 12.82 ± 4.05, revealing a low level of loneliness. A weak sense of belonging was related with a higher level of loneliness (ß = 0.096, p = 0.014). Migration pattern was found to exacerbate this association (ß = 0.138, p = 0.026), especially for the elderly who migrated across provinces. CONCLUSIONS: Sense of belonging was correlated with loneliness, and the moderating role of migration pattern was established. Both policymakers and the adult children of inter-provincial migrant elderly should focus on this special subgroup.

Corrigendum: Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers.

[This corrects the article DOI: 10.3389/fphar.2021.660541.].

D-Allulose (D-Psicose) Biotransformation From Allitol by a Newly Found NAD(P)-Dependent Alcohol Dehydrogenase From Gluconobacter frateurii NBRC 3264 and the Enzyme Characterization.

The NAD(P)-dependent alcohol dehydrogenase (ADH) gene was cloned from Gluconobacter frateurii NBRC 3264 and expressed in Escherichia coli BL21 star (DE3). The expressed enzyme was purified and the characteristics were investigated. The results showed that this ADH can convert allitol into D-allulose (D-psicose), which is the first reported enzyme with this catalytic ability. The optimum temperature and pH of this enzyme were 50°C and pH 7.0, respectively, and the enzyme showed a maximal activity in the presence of Co2+. At 1 mM Co2+ and allitol concentrations of 50, 150, and 250 mM, the D-allulose yields of 97, 56, and 38%, respectively, were obtained after reaction for 4 h under optimal conditions, which were much higher than that obtained by using the epimerase method of about 30%.

The relationship between oral health status, loneliness, and sleep quality among the migrant elderly following children in Weifang, Shandong Province, China: A comparative analysis on different migration types.

Background: The migrant elderly following children (MEFC) are a vulnerable group that emerged during fast urbanization in China. The MEFC faced physical and psychological discomfort upon their arrival in the inflow city, particularly those who came from rural areas. Objective: This study aimed to explore the relationship between oral health status, loneliness, and sleep quality among the MEFC in China and to clarify the disparities in the above mentioned relationship by migration type. Methods: In 2021, a cross-sectional survey was conducted in Weifang, Shandong Province, using multistage cluster random sampling to collect data from the MEFC aged 60 years and over. In total, 613 respondents [525 rural-to-urban (RTU) and 88 urban-to-urban (UTU)] were included in the final database. The chi-square test, t-test, and structural equation modeling (SEM) were used to investigate the relationship between oral health status, loneliness, and sleep quality among the RTU and UTU MEFC. Results: Total scores [mean ± standard deviation (SD)] for oral health status, loneliness, and sleep quality were 54.95 ± 6.47, 8.58 ± 3.03, and 4.47 ± 3.60, respectively. SEM revealed that, among the RTU and UTU MEFC, oral health status was positively and significantly related to sleep quality; however, the correlation was slightly stronger in the UTU MEFC. In both groups, there was a significant negative correlation between oral health status and loneliness, which was stronger in the UTU MEFC. In the RTU MEFC, a significant negative correlation between loneliness and sleep quality was observed, and in the UTU MEFC, no significant association between loneliness and sleep quality was observed. Conclusion: The sleep quality among the MEFC in this study was higher compared to previous studies. Oral health status was negatively correlated with loneliness and positively associated with sleep quality, whereas loneliness was negatively correlated with sleep quality. These three associations differed significantly between the UTU and RTU MEFC. The government, society, and families should take measures to improve oral health and reduce loneliness among the MEFC to improve their sleep quality.

A randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers.

BACKGROUND: Humira® is a fully humanized anti-tumor necrosis factor (TNF-α) monoclonal antibody that has been marketed and approved in the United States for the clinical treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis and other immune-mediated diseases. This study compared the bioequivalence, immunogenicity and safety of adalimumab injecta (a biosimilar of Humira® produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd) and Humira® in healthy Chinese male subjects in a phase I clinical study. METHODS: Healthy Chinese male subjects (N = 164) were randomly given a subcutaneous injection of 40 mg adalimumab or Humira® at a 1:1 ratio. Plasma drug concentrations were detected by enzyme-linked immunosorbent assay (ELISA), and primary pharmacokinetic (PK) parameters were statistically analyzed. To evaluate drug immunogenicity, anti-drug antibody (ADA) and neutralizing antibody (nAb) levels were detected. To evaluate the safety of the drugs, the subjects' physical indicators, such as multiple vital signs and routine blood tests, were continuously monitored. RESULTS: The similarity ratios of adalimumab and Humira® PK parameters were all within 80%-125%, meeting the bioequivalence standards. Drug-induced ADA and nAb levels were similar, and the drug safety in subjects was also similar. CONCLUSIONS: All study drugs showed similar bioequivalence, immunogenicity and safety. CLINICAL TRIAL REGISTRATION: CTR20182070 (Chinese Clinical Trial Registry).

A randomized, double-blind, single-dose, single-center, parallel phase I clinical study comparing the pharmacokinetics, immunogenicity, safety, and tolerance of pertuzumab injection and Perjeta® in healthy Chinese male subjects.

BACKGROUND: Perjeta® is a recombinant, humanized monoclonal antibody that has been marketed and approved for the targeted therapy of human epidermal growth factor receptor (HER2) positive breast cancer in the United States. This study compared the bioequivalence, immunogenicity, and safety of pertuzumab injection (a biosimilar of Perjeta® produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd) and Perjeta® (produced by Roche Pharma AG) in healthy Chinese males. RESEARCH DESIGN AND METHODS: Healthy Chinese male subjects (N = 87) were randomly given intravenous injection of 5 mg/kg pertuzumab or Perjeta® at a 1:1 ratio. Plasma drug concentrations were detected by enzyme-linked immunosorbent assay, and primary pharmacokinetic parameters were statistically analyzed. We detected the levels of anti-drug antibody (ADA) and neutralizing antibody (nAb) to evaluate drug immunogenicity and safety of the drugs throughout the study. RESULTS: The geometric mean ratios of AUC0-t, Cmax, and AUC0-∞ for pertuzumab and Perjeta® were 100.42%, 96.71%, and 101.47%, respectively. The 90% CIs were all within 80%-125%, meeting the bioequivalence standards. The levels of ADA and nAb were similar. In addition, both had good safety in the study. CONCLUSION: The study shows that pertuzumab injection and Perjeta® had similar bioequivalence, immunogenicity, and safety.

A randomized, double-blind, single-dose, parallel phase I clinical trial to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar and bevacizumab in healthy Chinese subjects.

BACKGROUND: Bevacizumab, a humanized monoclonal antibody against VEGF, can be used as a target therapy for colorectal cancer. A phase I clinical trial was conducted to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Bevacizumab (Roche Diagnostics GmbH) in healthy Chinese males. RESEARCH DESIGN & METHOD: Healthy Chinese subjects (N = 98) were randomly divided into two groups. A single-dose bevacizumab biosimilar or Bevacizumab was given per cycle. Plasma drug concentrations were detected by liquid chromatography-tandem mass spectrometry (LC-MC/MS) assay. We detected the levels of anti-drug antibody (ADA) to evaluate drug immunogenicity and the safety of drugs throughout the study. RESULTS: The geometric mean ratios (GMRs) of AUC0-t, Cmax, and AUC0-∞ for bevacizumab biosimilar and Bevacizumab were 96.27%, 93.69%, and 97.01%, respectively. The 90% CIs were all within 80-125%, meeting the bioequivalence standards. The levels of ADA were similar. In addition, the two drugs both demonstrated excellent safety in the trial. CONCLUSION: This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects.

Pharmacokinetics and safety of the two oral cefaclor formulations in healthy chinese subjects in the fasting and postprandial states.

We conducted a phase I bioequivalence trial in healthy Chinese subjects in the fasting and postprandial states. The goal of this trial was to compare the pharmacokinetics and safety of the test preparation Cefaclor granule (Disha Pharmaceutical Group Co., Ltd.) and the reference preparation Cefaclor suspension (Ceclor®, Eli Lilly and Company). In this trial, 24 subjects were selected in the fasting and postprandial states, respectively. Enrolled subjects randomly accepted a single dose of 0.125 g Cefaclor granule or Cefaclor suspension. The washout period was set as 2 days. Blood samples were collected within 8 h after administration in the fasting state and within 10 h after administration in the postprandial state. Plasma concentrations were determined by Liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters (AUC, Cmax) were used to evaluate bioequivalence of the two drugs. In the fasting trial, the geometric mean ratios (90% confidence intervals CIs) for Cmax, AUC0-t, and AUC0-∞ were 93.01% (85.96%-100.63%), 97.92% (96.49%-99.38%) and 97.95% (96.52%-99.41%), respectively. The GMR (90% CIs) for Cmax, AUC0-t, and AUC0-∞ in postprandial state were 89.27% (81.97%-97.22%), 97.31% (95.98%-98.65%) and 97.31% (95.93%-98.71%), respectively. The 90% CIs of AUC and Cmax in the fasting and postprandial states were within the 80-125% bioequivalence range. Therefore, Cefaclor granule and Cefaclor suspension were bioequivalent and displayed similar safety profiles. Furthermore, food intake affected the pharmacokinetic parameters of both drugs.