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临床试验/NCT04099732
NCT04099732已完成1 期

Relative Bioavailability of Rosuvastatin (Part 1) and Dabigatran (Part 2) Given Alone and Together With BI 1358894 in Healthy Male Subjects (Open, Single-dose, Fixed Sequence, Two-period Crossover Design in Each Trial Part)

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年10月7日最近更新:
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
26
试验地点
1
主要终点
Part1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

研究概览

简要总结

The main objective of this trial is to investigate the relative bioavailability of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1358894 (Test 1, Test 2) following oral administration.

研究设计

研究类型
Interventional
分配方式
Non 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 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Part 1: Reference 1 followed by Test 1

Experimental

Reference 1 - Rosuvastatin. Test 1 - Rosuvastatin + BI 1358894

干预措施: Rosuvastatin (Drug)

Part 1: Reference 1 followed by Test 1

Experimental

Reference 1 - Rosuvastatin. Test 1 - Rosuvastatin + BI 1358894

干预措施: BI 1358894 (Drug)

Part 2: Reference 2 followed by Test 2

Experimental

Reference 2 - Dabigatran etexilate. Test 2 - Dabigatran etexilate + BI 1358894

干预措施: BI 1358894 (Drug)

Part 2: Reference 2 followed by Test 2

Experimental

Reference 2 - Dabigatran etexilate. Test 2 - Dabigatran etexilate + BI 1358894

干预措施: Dabigatran etexilate (Device)

结局指标

主要结局

Part1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

时间窗: Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (1): within 3 hours before and up to 96 hours after drug administration. Detailed timeframe is provided in the description section.

Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration. Rosuvastatin + BI 1358894 (Test 1) was measured within 3 hours before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration.

Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax)

时间窗: Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (T1): within 3 hours before and up to 96 hours after drug administration. Detailed timeframe is provided in the description section.

Maximum measured concentration of the analyte (rosuvastatin) in Plasma (Cmax). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration. Rosuvastatin + BI 1358894 (Test 1) was measured within 3 hours before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 48h, 72h and 96h after drug administration.

Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

时间窗: Dabigatran (2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.

Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Dabigatran + BI 1358894 (Test 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration.

Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax)

时间窗: Dabigatran (R2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.

Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax). Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Dabigatran + BI 1358894 (Test 2) was measured within 3h before drug administration and 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration.

次要结局

  • Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Rosuvastatin (R1): within 3 hours before and up to 96 hours after drug administration. Rosuvastatin + BI 1358894 (T1): within 3 hours before and up to 96 hours after drug administration. .Detailed time frame is in description section.)
  • Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Dabigatran (R2): within 3 hours before and up to 72 hours after drug administration. Dabigatran + BI 1358894 (T2): within 3 hours before and up to 72 hours after drug administration. Detailed time frame is in description section.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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