Relative Bioavailability of Both BI 10773 and Warfarin and Pharmacodynamics of Warfarin After Co-administration Compared to Multiple Oral Doses of BI 10773 (25 mg Once Daily) and a Single Oral Dose of Warfarin (25 mg) Alone in Healthy Male Volunteers (an Open-label, Crossover, Clinical Phase I Study)
Abstract
The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.
Conditions: Healthy.
Primary outcome: Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss); Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss); Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞); Warfarin R-enantiomers: Maximum Measured Concentration (Cmax); Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞); Warfarin S-enantiomers: Maximum Measured Concentration (Cmax).
Enrollment: 18 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 18 participants or records.
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