An Open-label, One-sequence Crossover Study of Favipiravir to Evaluate the Effects on the Pharmacokinetics of Triazolam/Metformin Hydrochloride in Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 主要终点
- Plasma concentration versus time profile and plasma PK parameters of triazolam
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 39age old under（—）
- 性别
- Male
入选标准
- •(1) Subjects between 20 and 39 years of age (inclusive) at informed consent
- •(2) Gender: Male subjects
- •(3) Subjects with BMI in the range of 18.5 or more and less than 30.0 kg/m2 and body weight 55 kg or more
- •(4) Subjects who understand the objectives of the study, volunteer to participate in the study, are able to provide written informed consent, and confirmed the intention to continue participating in the study
排除标准
- •(1) Subjects with a medical history of gastrointestinal, skin, renal, hepatic, neurological, hematological, endocrine, cancer, respiratory, immunological, psychological, cardiovascular, or other diseases that is considered to affect safety of the subjects and evaluation of pharmacokinetics/safety of the study drug by the principal investigator or subinvestigator
- •(2) Subjects with a history of surgery or a disease condition that is considered by the principal investigator or subinvestigator to affect the absorption, distribution, metabolism, and excretion of the study drug
- •(3) Subjects who have previously received favipiravir
- •(4) Subjects who are deemed to be ineligible for the study by the principal investigator or subinvestigator
结局指标
主要结局
Plasma concentration versus time profile and plasma PK parameters of triazolam
Plasma concentration versus time profile and plasma PK parameters of triazolam (Cohort 1)
Geometric mean ratios of Cmax, AUC0-t and AUCinf of triazolam in combination with favipiravir compared with those of triazolam alone and their 90% confidence intervals
Geometric mean ratios of Cmax, AUC0-t and AUCinf of triazolam in combination with favipiravir compared with those of triazolam alone and their 90% confidence intervals (Cohort 1)
Plasma concentration versus time profile and plasma PK parameters of metformin
Plasma concentration versus time profile and plasma PK parameters of metformin (Cohort 2)
Geometric mean ratios of Cmax, AUC0-t and AUCinf of metformin in combination with favipiravir compared with those of metformin alone and their 90% confidence intervals
Geometric mean ratios of Cmax, AUC0-t and AUCinf of metformin in combination with favipiravir compared with those of metformin alone and their 90% confidence intervals (Cohort 2)
Plasma concentration versus time profile and plasma PK parameters of favipiravir and favipiravir hydroxide metabolite (M1)
Plasma concentration versus time profile and plasma PK parameters of favipiravir and favipiravir hydroxide metabolite (M1) (Cohort 1 and 2)
次要结局
未报告次要终点