Effect of Multiple Dosing With 240 mg BID BI 201335 on the Steady State Pharmacokinetics of 300mg QD Tenofovir and Effect of Multiple Dosing With 300mg QD Tenofovir on Steady State BI 201335 Pharmacokinetics in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
研究概览
简要总结
The objective of this study is to evaluate the drug-drug interaction potential between BI 201335 and concomitantly administered tenofovir which is used in treatment regimens for HIV infection and/or Hepatitis B infection. Results of this study will serve as a basis for guidance of dose adjustments or other precautionary measures when BI201335 and tenofovir are coadministered.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
sequence 1
tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through day 22 (morning dose on day 22 only)
干预措施: tenofovir/BI 201335 (Drug)
结局指标
主要结局
Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
时间窗: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.
Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
时间窗: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
时间窗: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.
Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22
时间窗: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.
Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
时间窗: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Maximum measured concentration of analyte in plasma (Cmax), at steady state.
Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
时间窗: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.
次要结局
- Number of Patients With Drug Related Adverse Events During the Trial(From drug administration up to 32 days.)
- Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG(From drug administration up to 32 days.)