drugset / Trial / NCT02171624

Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate

NCT02171624

Phase 1 Completed 42 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

Open-label, two-way crossover design with a quinidine sulfate run-in period followed by a randomised sequence of dabigatran etexilate plus quinidine sulfate or dabigatran etexilate alone to evaluate the safety of co-administration of dabigatran etexilate and quinidine. and the pharmacokinetic interaction between quinidine and dabigatran etexilate.

Timeline

Start
2009-03
Primary completion
2009-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 150 mg
Subject Quinidine Small molecule 200 mg Oral

Indications

No indication recorded.