drugset / Trial / NCT02221388

Relative Bioavailability of Different Formulations of BI 671800 in Healthy Male and Female Volunteers

NCT02221388

Phase 1 Completed 24 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

To compare the oral bioavailability and rate of absorption of two different formulations of BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA formulations were further investigated concerning food effect and one of the two BI 671800 HEA formulations identified by interim pharmacokinetic analysis was further investigated concerning dose proportionality with 50 mg.

Timeline

Start
2010-02
Primary completion
2010-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 671800 Small molecule 50 mg Oral
Subject BI 671800 Small molecule 200 mg Oral

Indications

No indication recorded.