drugset
drugset / Trial / NCT02170116

Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers

NCT02170116 ↗

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

Summary

The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048 MS, in healthy male subjects. This was the first administration of this substance to humans.

Timeline

Start
1998-11
Primary completion
1998-12
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 10 mg Oral
Subject Dabigatran etexilate Unknown 30 mg Oral
Subject Dabigatran etexilate Unknown 100 mg Oral
Subject Dabigatran etexilate Unknown 200 mg Oral
Subject Dabigatran etexilate Unknown 400 mg Oral

Indications

No indication recorded.