The main objectives of this trial are to investigate the relative bioavailabilities of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1323495 (Test 1, Test 2) following oral administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax)
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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Time frame: Measured within 3 hours (h) before and up to 95h 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 Extrapolated to Infinity (AUC0-∞)
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 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
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Capsule and tablets
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax)
Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.
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)
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 (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, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 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, 47h, 71h and 95h after drug administration.
Time frame: Measured within 3 hours (h) before and up to 95h 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)
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 (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration.
Time frame: Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section.