Bioequivalence of 1 Soft Gelatine Capsule Containing 200 mg Nintedanib Compared to 2 Soft Gelatine Capsules Containing 100 mg Nintedanib Following Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- AUC0-tz
研究概览
简要总结
To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib compared to 2 soft gelatine capsules containing 100 mg nintedanib
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
- 18 Years 至 50 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 R - 2 (Reference)
Nintedanib, 2 capsules, oral with 240 mL of water
干预措施: Nintedanib (Drug)
Treatment T (Test)
Nintedanib, 1 capsule, oral with 240 mL of water
干预措施: Nintedanib (Drug)
Treatment R - 1 (Reference)
Nintedanib, 2 capsules, oral with 240 mL of water
干预措施: Nintedanib (Drug)
结局指标
主要结局
AUC0-tz
时间窗: -1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference treatment 1 (R1) and Reference treatment 2 (R2) separately.
Cmax
时间窗: -1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.
Maximum measured concentration of the analyte in plasma (Cmax). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.
次要结局
- AUC0-inf(-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.)