Effect of high-fat diet on the pharmacokinetics and safety of flumatinib in healthy Chinese subjects.

PURPOSE: To evaluate the effect of a high-fat diet on the pharmacokinetics and safety of flumatinib mesylate tablets in healthy Chinese subjects. METHODS: This study was a randomized, open-label, single-dose, two-period crossover trial in which subjects were randomly assigned to take 400 mg of flumatinib mesylate after a high-fat diet or a fasted state. After a 14-day washout period, the two groups were administered flumatinib mesylate under opposite conditions. Blood samples were collected at baseline 0 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, and 96 h, respectively. Plasma concentrations of flumatinib and its metabolites (M1 and M3) were analyzed using liquid chromatography-mass spectrometry. Pharmacokinetic parameters were calculated using the non-compartmental module of the Phoenix WinNonlin Version 7.0 software. BE module of WinNonLin was used for statistical analysis of AUC0-t, AUC0-∞ and Cmax in plasma. RESULTS: Twelve healthy subjects, half male and half female, were enrolled. One subject withdrew due to a treatment-emergent adverse event. Eleven subjects were administered drugs on fasting and 12 were administered drugs after a high-fat diet. On high-fat diet/fasting, the least square geometric mean (LSGM) ratios of flumatinib, M1, M3, and their 90% confidence interval (CI) were as follows: for flumatinib, Cmax, AUC0-t and AUC0-∞ were 281.65% (225.80-351.31%), 167.43% (143.92-194.79%), and 166.87% (143.47-194.09%); for M1, Cmax, AUC0-t, and AUC0-∞ were 188.59% (145.29-244.79), 163.94% (149.11-180.24%), and 164.48% (150.36-179.94%); for M3, Cmax, AUC0-t, and AUC0-∞ were 63.47% (54.02-74.57%), 85.23% (74.72-97.22%), and 96.73% (86.63-108.02%). CONCLUSION: Among the subjects, oral administration of 400 mg of flumatinib was safe and well tolerated. High-fat diet significantly increases the exposure to flumatinib, therefore, fasting may be recommended. CLINICAL TRIAL REGISTRATION: The study was registered at chictr.org Identifier: ChiCTR-IIR-17013179.

The prevalence of glucose metabolism disturbances in Chinese Muslims and possible risk factors: a study from northwest China.

OBJECTIVE: To survey the prevalence of diabetes mellitus (DM) and pre-diabetes mellitus (PDM) in the Muslim population in northwest China, and discuss the risk factor. MATERIALS AND METHODS: According to the income and the population, we randomly selected 3 villages with stratified and cluster sampling. The subjects were residents ≥ 20 years of age, and were from families which have been local for > 3 generations. The questionnaire and oral glucose tolerance test (OGTT) were completed and analyzed for 660 subjects. RESULTS: The prevalence of DM and PDM between the Han and Muslim populations were different (P = 0.041). And the prevalence were also different with respect to age in the Han (P < 0.001) and Muslim population (P < 0.001) respectively. Except for the 20-year-old age group the prevalence of DM and PDM within the Muslim population was higher than the Han (P = 0.013), we did not find any significant difference for other age groups (P > 0.05). The intake of salt (P < 0.001) and edible oil (P < 0.001) in the Muslim population was higher than the Han, while cigarette smoking (P < 0.001) and alcohol consumption (P < 0.001) was lower. BMI (P < 0.001), age (P = 0.025), and smoking cigarettes (P = 0.011) were risk factors for DM and PDM, but alcohol consumption (P < 0.001) was a protective factor. CONCLUSIONS: In northwest China, the prevalence of DM was higher in the Muslim population, and it was special higher on the 20-year-old age compared to the Han. This might be explained by the potential genetic differences and poor dietary habits.

The prevalence of glucose metabolism disturbances in Chinese Muslims and possible risk factors: a study from northwest China / Prevalência e possíveis fatores de risco de distúrbios no metabolismo da glicose em chineses muçulmanos: um estudo no noroeste da China

Objective To survey the prevalence of diabetes mellitus (DM) and pre-diabetes mellitus (PDM) in the Muslim population in northwest China, and discuss the risk factor. Materials and methods According to the income and the population, we randomly selected 3 villages with stratified and cluster sampling. The subjects were residents ≥ 20 years of age, and were from families which have been local for > 3 generations. The questionnaire and oral glucose tolerance test (OGTT) were completed and analyzed for 660 subjects. Results The prevalence of DM and PDM between the Han and Muslim populations were different (P = 0.041). And the prevalence were also different with respect to age in the Han (P < 0.001) and Muslim population (P < 0.001) respectively. Except for the 20-year-old age group the prevalence of DM and PDM within the Muslim population was higher than the Han (P = 0.013), we did not find any significant difference for other age groups (P > 0.05). The intake of salt (P < 0.001) and edible oil (P < 0.001) in the Muslim population was higher than the Han, while cigarette smoking (P < 0.001) and alcohol consumption (P < 0.001) was lower. BMI (P < 0.001), age (P = 0.025), and smoking cigarettes (P = 0.011) were risk factors for DM and PDM, but alcohol consumption (P < 0.001) was a protective factor. Conclusions In northwest China, the prevalence of DM was higher in the Muslim population, and it was special higher on the 20-year-old age compared to the Han. This might be explained by the potential genetic differences and poor dietary habits. .

Objetivo Avaliar a prevalência de diabetes melito (DM) e pré-diabetes melito (PDM) na população muçulmana no noroeste da China e discutir os fatores de risco. Materiais e métodos Selecionamos três vilarejos de acordo com a renda e a população, usando uma amostra estratificada e por cluster. Os sujeitos eram residentes com ≥ 20 anos de idade e de famílias que estavam no local há mais de três gerações. Foram feitos e analisados um questionário e o teste de tolerância oral à glicose (TTOG) para 660 sujeitos. Resultados A prevalência do DM e PDM entre as populações Han e muçulmana foi diferente (P = 0,041), e as prevalências também foram diferentes com relação à idade na população Han (P < 0,001) e muçulmana (P < 0,001), respectivamente. Exceto pela faixa etária de 20 anos de idade, a prevalência do DM e PDM na população muçulmana foi maior do que na população Han (P = 0,013), não havendo diferenças significativas para as outras faixas etárias (P > 0,05). A ingestão de sal (P < 0,001) e óleos comestíveis (P < 0,001) na população muçulmana foi mais alta do que na população Han, enquanto o tabagismo (P < 0,001) e consumo de álcool (P < 0,001) foram mais baixos. O IMC (P < 0,001), a idade (P = 0,025) e o tabagismo (P = 0,011) foram fatores de risco para o DM e PDM, mas o consumo de álcool (P < 0,001) foi um fator protetor. Conclusões No noroeste da China, a prevalência de DM é maior na população muçulmana e é especialmente mais alta na faixa etária de 20 anos de idade, quando comparada com a população Han. Isso pode ser explicado por diferenças genéticas potenciais e hábitos alimentares ruins. .