Bioequivalence and Food Effect Assessment of 2 Rivaroxaban Formulations in Healthy Chinese Volunteers: An Open, Randomized, Single‐Dose, and 4‐Period Crossover Study

2021 ◽  
Author(s):  
Ye Tao ◽  
Xin Jiang ◽  
Ping Shi ◽  
Yanping Liu ◽  
Pingping Lin ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Food Effect ◽  
Effect Assessment ◽  
Healthy Chinese

Relative bioavailability of two formulations of nevirapine 200-mg tablets in healthy Chinese male volunteers: A single-dose, randomized-sequence, open-label, two-way crossover study

2010 ◽  
Vol 32 (13) ◽  
pp. 2258-2264 ◽  
Author(s):  
Yubing Zhu ◽  
Qian Zhang ◽  
Cuixia Yu ◽  
Jianjun Zou ◽  
Xiaohong Yang ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Relative Bioavailability ◽  
Open Label ◽  
Male Volunteers ◽  
Healthy Chinese ◽  
Chinese Male

scholarly journals Pharmacokinetics and Bioequivalence of Two Formulations of Valsartan 80 mg Capsules: A Randomized, Single Dose, 4-Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed Conditions

2020 ◽  
Vol Volume 14 ◽  
pp. 4221-4230
Author(s):  
Qingqing Wu ◽  
Xiaodong Wang ◽  
Qian Chen ◽  
Yang Zou ◽  
Xiaoyan Xu ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Chinese

scholarly journals Pharmacokinetic properties and bioequivalence of two formulations of arbidol: An open-label, single-dose, randomized-sequence, two-period crossover study in healthy chinese male volunteers

2009 ◽  
Vol 31 (4) ◽  
pp. 784-792 ◽  
Author(s):  
Ming-Yan Liu ◽  
Shuang Wang ◽  
Wei-Fan Yao ◽  
Hui-zhe Wu ◽  
Sheng-Nan Meng ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Open Label ◽  
Male Volunteers ◽  
Pharmacokinetic Properties ◽  
Healthy Chinese ◽  
Chinese Male

Pharmacokinetics and bioequivalence evaluation of two losartan potassium 50-mg tablets: A single-dose, randomized-sequence, open-label, two-way crossover study in healthy Chinese male volunteers

2010 ◽  
Vol 32 (7) ◽  
pp. 1387-1395 ◽  
Author(s):  
Jing-Ying Jia ◽  
Meng-Qi Zhang ◽  
Yan-Mei Liu ◽  
Yun Liu ◽  
Gang-Yi Liu ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Losartan Potassium ◽  
Open Label ◽  
Male Volunteers ◽  
Healthy Chinese ◽  
Chinese Male

scholarly journals A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Tolerance, Pharmacokinetics of Jaktinib, a New Selective Janus Kinase Inhibitor in Healthy Chinese Volunteers

2020 ◽  
Vol 11 ◽  
Author(s):  
Jingrui Liu ◽  
Binhua Lv ◽  
Hewen Yin ◽  
Xiaoxue Zhu ◽  
Haijing Wei ◽  
...  
Keyword(s):  
Single Dose ◽  
Adverse Events ◽  
Phase I ◽  
Multiple Dose ◽  
Food Effect ◽  
Effect Study ◽  
Janus Kinase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Chinese

Background: Jaktinib is a novel selective janus kinase 1/2 inhibitor. The phase I first-in-human study evaluated the tolerance and pharmacokinetics of jaktinib in healthy Chinese subjects.Methods: A randomized, double-blind, placebo-controlled study were designed. A total of 126 healthy subjects were enrolled into the single ascending dose, multiple ascending dose and food effect study. Safety endpoints included adverse events, abnormal vital signs, 12-lead ECGs, abdominal ultrasound, chest x-ray, physical examination and clinical laboratory tests. Blood, urine and feces samples were collected at predetermined time points for pharmacokinetic analysis of jaktinib, the metabolites ZG0244 and ZG0245, which are formed by oxidation or hydrolysis metabolic pathway, respectively.Results: Jaktinib was absorbed with a median time to peak plasma concentration of 1.25–3.5 h and was eliminated with a half-life of 2.952–9.040 h. Linear pharmacokinetic characteristic was presented over the dose range from 25 to 400 mg. No obvious accumulation was observed after multiple doses for 10 days. Administration after a high-fat breakfast significantly increased the absorption of jaktinib. The accumulated fraction of jaktinib and the determined metabolites excreted in urine and feces was 19.478%. Jaktinib was well tolerated in all single dose cohorts. In multiple dose cohorts, 200 mg q24 h method was evaluated as maximally tolerated dose. Neutropenia, diarrhea, dizziness and headache were the most frequently reported treatment related adverse events. No deaths, serious or Grade ≥4 adverse events was developed.Conclusion: Jaktinib was well tolerated when single dose ranging from 25 to 400 mg and multiple dose up to 200 mg q24 h. The safety and pharmacokinetic characteristics support the next trial in myelofibrosis patients.

Pharmacokinetics and Bioequivalence Evaluation of Two Acipimox Tablets: A Single-Dose, Randomized-Sequence, Two-Way Crossover Study in Healthy Chinese Male Volunteers

Drug Research ◽  
2013 ◽  
Vol 63 (02) ◽  
pp. 79-83 ◽  
Author(s):  
J. Huang ◽  
R. Chen ◽  
C. Wei ◽  
R. Li ◽  
G. Yuan ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Male Volunteers ◽  
Healthy Chinese ◽  
Chinese Male
Sign in / Sign up

Export Citation Format

Share Document