Investigating BI 425809 Drug Interactions
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Corresponding Organization : Boehringer Ingelheim (India)
Other organizations : Boehringer Ingelheim (Germany), Boehringer Ingelheim (United States), Friedrich-Alexander-Universität Erlangen-Nürnberg, Boehringer Ingelheim (Japan)
Variable analysis
- Administration of BI 425809 25 mg once daily on days 1 to 14 in period 2
- Pharmacokinetic parameters of midazolam, warfarin, omeprazole, and digoxin
- Fasting overnight for at least 10 hours before dosing and for 4 hours afterward on days 1 and 2 of period 1 and days 10 and 11 of period 2
- Washout period of ≥5 days between period 1 and period 2
- Single dose of a probe-drug cocktail containing midazolam (2 mg), warfarin (10 mg), and omeprazole (20 mg) on day 1 of period 1 and day 10 of period 2
- Single dose of digoxin (0.25 mg) on day 2 of period 1 and day 11 of period 2
- None specified
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