Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximum Measured Concentration (Cmax)
研究概览
简要总结
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 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
Treatment sequence 2
Reference - Test - Test - Reference
干预措施: BI 201335 NA 120 mg capsule (Drug)
Treatment sequence 1
Test - Reference - Reference - Test
干预措施: BI 201335 NA 120 mg capsule (Drug)
Treatment sequence 1
Test - Reference - Reference - Test
干预措施: BI 201335 NA 40 mg capsule (Drug)
Treatment sequence 2
Reference - Test - Test - Reference
干预措施: BI 201335 NA 40 mg capsule (Drug)
结局指标
主要结局
Maximum Measured Concentration (Cmax)
时间窗: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
次要结局
- Time From Dosing to the Maximum Measured Concentration (Tmax)(3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration)
- Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)(3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration)
- Mean Residence Time (MRTpo)(3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration)
- Terminal Rate Constant (λz)(3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration)
- Terminal Half-life (t1/2)(3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration)