NCT01612143已完成1 期
A Randomized, Open-label, Single Dose, Cross-over Study to Investigate the Relative Bioavailability of Setrobuvir (STV) Tablet Formulation Versus the Reference Setrobuvir Capsule Formulation Following Oral Administration With or Without a High Fat Meal in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Relative bioavailability: Cmax/area under the concentration-time curve (AUC)
研究概览
简要总结
This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule formulation in healthy volunteers. Subjects will be randomized to one of four treatment sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule formulation with or without a high fat meal, with a washout period of at least 14 days between treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults, 18 to 55 years of age inclusive
- •Body mass index (BMI) 18.0 - 30.0 kg/m2
- •Healthy status defined as absence of clinically significant acute or chronic condition as determined by complete medical history and physical examination
- •Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception as defined by protocol during treatment and for at least 3 months after the last dose of study drug
- •Non-smokers or use of < 10 cigarettes (or equivalent nicotine-containing product) per day
- •Negative results on following screening laboratory test: urine drug screen, urine alcohol screen
- •Willing and able to consume the study-specified meal on day of dosing
排除标准
- •Pregnant or lactating women, or males with female partners who are pregnant or lactating
- •History of current alcohol abuse and/or other drug addiction </= 2 years prior to enrollment in the study
- •Participation in other clinical studies within 60 days prior to study randomization
- •Positive for hepatitis B, hepatitis C or HIV infection
研究组 & 干预措施
A: STV capsule (after high fat meal)
Active Comparator
干预措施: setrobuvir (Drug)
B: STV capsule (fasted state)
Active Comparator
干预措施: setrobuvir (Drug)
D: STV tablet (fasted state)
Experimental
干预措施: setrobuvir (Drug)
C: STV tablet (after high fat meal)
Experimental
干预措施: setrobuvir (Drug)
结局指标
主要结局
Relative bioavailability: Cmax/area under the concentration-time curve (AUC)
时间窗: Pre-dose and up to 168 hours post-dose
次要结局
- Safety: Incidence of adverse events(approximately 2 months)
研究者
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