drugset
drugset / Trial / NCT02170844

Safety, Pharmacokinetics and Pharmacodynamics After Single Rising Oral Doses of BIBR 1048 MS as Capsules in Healthy Subjects of Japanese and Caucasian Origin

NCT02170844 ↗

Phase 1 Completed 40 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

To investigate and compare safety, pharmacokinetics and pharmacodynamics of BIBR 1048 MS following oral administration of single rising doses from 50 mg to 350 mg in healthy male subjects of Japanese and Caucasian origin. This was the first administration of this substance to subjects of Japanese origin.

Timeline

Start
2004-06
Primary completion
2004-08
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 50 mg Oral
Subject Dabigatran etexilate Unknown 150 mg Oral
Subject Dabigatran etexilate Unknown 350 mg Oral

Indications

No indication recorded.