drugset
drugset / Trial / NCT02170584

Tolerability of BIBR 953 ZW IV and Bioavailability of BIBR 1048 Tablet and Solution in Healthy Males

NCT02170584 ↗

Phase 1 Completed 30 enrolled Boehringer Ingelheim
RandomizedCrossoverDouble-blindTreatment

Summary

Two substudies to assess (1) the tolerability of BIBR 953 ZW intravenous infusion at 0.1, 1 and 5 mg BIBR 953 ZW and (2) the absolute bioavailability of 100mg BIBR 1048 administered as 'acid free' tablet formulation (TF1) and (3) the bioavailability of the 100 mg tablet of BIBR 1048 relative to the tartaric acid solution of 100 mg dose strength and (4) the absolute bioavailability of the 100 mg tartaric acid solution of BIBR 1048 MS.

Timeline

Start
2001-01
Primary completion
2001-03
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran Unknown 0.1 mg Intravenous
Subject Dabigatran Unknown 1 mg Intravenous
Subject Dabigatran Unknown 5 mg Intravenous
Subject Dabigatran etexilate Unknown 100 mg Oral

Indications

No indication recorded.