NCT01418274已完成1 期
A Study to Investigate the Effect of Multiple Doses of Danoprevir/Ritonavir (DNV/RTV) on the Pharmacokinetics (PK) of Escitalopram (ESC) and S-Demethylcitalopram (S-DCT) 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
- 20
- 主要终点
- Change in area under the plasma concentration time curve (AUC) of escitalopram
研究概览
简要总结
This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult healthy volunteers, aged 18 to 55 years, inclusive
- •Body mass index (BMI) 18.0 to 32.0 kg, inclusive
- •Absence of evidence of any active or chronic disease
- •Non-smokers
排除标准
- •Presence of any active or chronic disease
- •Abnormal blood pressure
- •Abnormal resting heart rate
- •Abnormal ECG values
- •History of any clinically significant cardiovascular or cerebrovascular disease
研究组 & 干预措施
Single arm
Experimental
干预措施: escitalopram (Drug)
Single arm
Experimental
干预措施: danoprevir (Drug)
Single arm
Experimental
干预措施: ritonavir (Drug)
结局指标
主要结局
Change in area under the plasma concentration time curve (AUC) of escitalopram
时间窗: Approximately 4 weeks
次要结局
- Safety: Incidence of adverse events(Approximately 6 weeks)
- Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram(Approximately 4 weeks)
- Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir(Approximately 4 weeks)
研究者
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