drugset
drugset / Trial / NCT02170909

Safety, Pharmacokinetics and Pharmacodynamics of BIBR 1048 MS Capsule in Healthy Male Subjects of Japanese and Caucasian Origin

NCT02170909 ↗

Phase 1 Completed 42 enrolled Boehringer Ingelheim
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Study to investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single (150 mg, 220 mg and 300 mg) and multiple (150 mg and 220 mg q.d. and 150 mg b.i.d.) rising doses in healthy male subjects of Japanese and Caucasian origin.

Timeline

Start
2004-12
Primary completion
2005-06
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 150 mg Oral
Subject Dabigatran etexilate Unknown 220 mg Oral
Subject Dabigatran etexilate Unknown 300 mg Oral

Indications

No indication recorded.