Hymenobacter terrae sp. nov., a bacterium isolated from soil.

A Gram-negative, UV tolerant bacterial strain, DG7A(T), was isolated from soil samples collected in Seoul city, South Korea. The cells were grown on R2A agar at 25 °C and were pink to red in color. The DNA G+C content of the novel strain DG7A was 63.5 mol%. Chemotaxonomic data revealed that the strains contain the major fatty acids iso-C15:0, anteiso-C15:0, and summed feature 3 (16:1 ω7c/16:1 ω6c), with phosphatidylethanolamine as the major polar lipid. Phylogenetic analysis of the 16S rRNA gene sequences showed that strain DG7A(T) formed a distinct phylogenetic line along with Hymenobacter soli PB17(T), and they shared approximately 98.35 % 16S rRNA gene sequence similarity. However, these two strains shared only 5.3 % pairwise similarity (reciprocal analysis, 36.3 %) in their genomic DNA. The next highest degree of 16S rRNA gene sequence similarity after H. soli PB17(T) was found with H. glaciei VUG-A130(T) (96.78 %), H. antarcticus VUG-A42aa(T) (96.66 %), and H. saemangeumensis GSR0100(T) (96.57 %). Based on the phylogenetic analysis and analysis of the physiological and biochemical characteristics, this isolate was considered to represent a novel species, for which we propose the name Hymenobacter terrae sp. nov., with type strain DG7A(T) (= KCTC 32554(T) = KEMB 9004-164(T )= JCM 30007(T)).

Spirosoma radiotolerans sp. nov., a gamma-radiation-resistant bacterium isolated from gamma ray-irradiated soil.

A Gram-negative, short-rod-shaped bacterial strain with gliding motility, designated as DG5A(T), was isolated from a rice field soil in South Korea. Phylogenic analysis using 16S rRNA gene sequence of the new isolate showed that strain DG5A(T) belong to the genus Spirosoma in the family Spirosomaceae, and the highest sequence similarities were 95.5 % with Spirosoma linguale DSM 74(T), 93.4 % with Spirosoma rigui WPCB118(T), 92.8 % with Spirosoma luteum SPM-10(T), 92.7 % with Spirosoma spitsbergense SPM-9(T), and 91.9 % with Spirosoma panaciterrae Gsoil 1519(T). Strain DG5A(T) revealed resistance to gamma and UV radiation. Chemotaxonomic data showed that the most abundant fatty acids were summed feature C(16:1) ω7c/C(16:1) ω6c (36.90 %), C(16:1) ω5c (29.55 %), and iso-C(15:0) (14.78 %), and the major polar lipid was phosphatidylethanolamine (PE). The DNA G+C content of strain DG5A(T) was 49.1 mol%. Together, the phenotypic, phylogenetic, and chemotaxonomic data supported that strain DG5A(T) presents a novel species of the genus Spirosoma, for which the name Spirosoma radiotolerans sp. nov., is proposed. The type strain is DG5A(T) (=KCTC 32455(T) = JCM19447(T)).

A Fixed-Dose Combination Of Gemigliptin And Rosuvastatin Exhibits Similar Pharmacokinetics, Pharmacodynamics, And Safety Compared To That Of A Loose Combination In Healthy Subjects.

PURPOSE: Fixed-dose combination (FDC) of gemigliptin and rosuvastatin may improve medication compliance of patients with comorbid type 2 diabetes and dyslipidemia. Pharmacokinetics (PK), pharmacodynamics (PD), and safety of gemigliptin/rosuvastatin 50/20 mg FDC was compared with a loose combination of individual tablets in healthy subjects. PATIENTS AND METHODS: A randomized, open-label, single-dose, two-period, two-sequence, two-treatment crossover study was conducted. Subjects received FDC or a loose combination of gemigliptin (50 mg) and rosuvastatin (20 mg) during each period, with a 14-day washout. Serial blood samples were collected up to 72 hrs after dosing to measure plasma concentrations of gemigliptin, its active metabolite LC15-0636, and rosuvastatin for PK assessment, and DPP-4 activity for PD assessment. PK and PD parameters were calculated using a non-compartmental method. Safety profiles were evaluated throughout the study. RESULTS: Thirty-seven subjects completed the study. The concentration-time profiles of gemigliptin, LC15-0636, and rosuvastatin were similar between FDC and loose combination, respectively. For each of the three compounds, the geometric mean ratios (90% confidence interval) of FDC to loose combination for Cmax and AUClast fell within the bioequivalence range of 0.8-1.25. Inhibition of DPP-4 activity-time profiles after administration of FDC and loose combination was overlapping, and Imax and AUEClast were similar. Both FDC and the loose combination were well tolerated. CONCLUSION: PK, PD, and safety profiles of gemigliptin, its metabolite, and rosuvastatin were similar between FDC and loose combination. The FDC of gemigliptin (50 mg) and rosuvastatin (20 mg) can be used as an alternative to a loose combination, which is expected to improve patient compliance.

Assessment of Appropriateness of an Initial Dosing Regimen of Vancomycin and Development of a New Dosing Nomogram.

Vancomycin is a glycopeptide antibiotic used to treat Gram-positive infections including methicillin-resistant Staphylococcus aureus (MRSA). The objectives of this study were to evaluate the appropriateness of the initial dosing regimen of vancomycin, identify factors to be considered in regimen selection and develop a new dosing nomogram. Therapeutic drug monitoring (TDM) data of vancomycin obtained from Seoul National University Hospital from 2011 to 2013 were included in this analysis. The vancomycin trough concentrations at steady-state were estimated using Abbott's PKS software program and then categorized into three levels: subtherapeutic, therapeutic and toxic. The newly developed nomograms were evaluated by analysing the percentage of patients with target vancomycin trough concentration using the data of 2,570 patients of the first TDM cases. Therapeutic level was achieved only in approximately one-fifth of the cases, while 56.0% and 23.8% of the TDMs were considered subtherapeutic and toxic, respectively. As body-weight and creatinine clearance (CrCL) increased, the proportion of patients with a subtherapeutic level increased. Using the newly developed nomogram increased the proportion of patients who achieved therapeutic levels from 23.1% to 45.0% or 13.8% to 36.2% (target, 10-15 and 15-20 mg/L, respectively). These results suggest that the vancomycin concentrations fail to reach the therapeutic level or exceed the safe upper margin of the therapeutic level depending on age, body-weight and CrCL. Considering these factors, the new nomograms provide a strategy to achieve target concentrations of vancomycin more rapidly than existing regimens.

A randomized, double-blind, single-dose, two-arm, parallel study comparing pharmacokinetics, immunogenicity and tolerability of branded adalimumab and its biosimilar LBAL in healthy male volunteers.

OBJECTIVES: This study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira®, in healthy volunteers. METHODS: A randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs). Tolerability was also evaluated. RESULTS: The PK characteristics of the test and reference drugs were comparable. The GMR (90% CIs) for Cmax and AUCinf of LBAL to Humira were 1.01 (0.92-1.11) and 0.96 (0.83-1.10), respectively, which were within the conventional bioequivalence criteria of 0.80-1.25. No significant differences occurred in the frequency of subjects with anti-adalimumab antibody-positive responses between both drugs. Tolerability profiles including adverse events were also comparable. CONCLUSION: The PK characteristics of the biosimilar LBAL and the originator Humira were similar. LBAL and Humira did not show significant differences in immunogenicity and both were well tolerated after a single SC injection.