A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
研究概览
简要总结
This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult healthy volunteers, aged 18 to 45 years, inclusive
- •Weight >/= 50.0 kg
- •Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive
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
- •Current smokers or subjects that have discontinued smoking < 6 months prior to first dose of study drug
- •Positive for hepatitis B, hepatitis C or HIV
- •Positive test for drugs of abuse or alcohol
- •Positive result for H. pylori
- •Regular use of antacids, H-2 blockers, proton pump inhibitors, or any investigational drug within 30 days of first dose of study medication
- •History of clinically significant gastrointestinal disease
研究组 & 干预措施
2
干预措施: ranitidine (Drug)
2
干预措施: ritonavir (Drug)
1
干预措施: danoprevir (Drug)
1
干预措施: ritonavir (Drug)
2
干预措施: danoprevir (Drug)
2
干预措施: omeprazole (Drug)
结局指标
主要结局
Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
时间窗: 1 day
Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
时间窗: 1 day
Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
时间窗: 1 day
次要结局
- Safety: Incidence of adverse events(Approximately 6 weeks)