jRCT2071210126进行中（未招募）不适用
A Phase I, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Injectable Favipiravir in Healthy 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
- Adverse events
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
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
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, and are able to provide written informed consent
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
Adverse events
To evaluate the safety and tolerability
Laboratory tests
To evaluate the safety and tolerability
Vital signs
To evaluate the safety and tolerability
Twelve-lead electrocardiogram
To evaluate the safety and tolerability
次要结局
- Plasma concentration versus time profile and plasma PK parameters of favipiravir and favipiravir hydroxide metabolite (M1)
- Urine PK parameters of favipiravir and M1
- Prediction of favipiravir plasma concentration by simulation using a mechanism based inhibition pharmacokinetics (MBI-PK) model
- Cmax, Cmin, daily AUC and cumulative AUC for each dosing day using MBI-PK model
- Attainment day of steady state
研究者
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