drugset / Trial / NCT02171715

BIBW 2992 Administered as Tablet (Final Formulation) Compared to BIBW 2992 Drinking Solution and BIBW 2992 Tablet (Trial Formulation II) in Healthy Male Volunteers

NCT02171715 ↗

Phase 1 Completed 22 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of the study was to investigate the relative bioavailability and pharmacokinetics of 20 mg BIBW 2992 administered as film-coated immediate release tablet (final formulation, i.e. phase III/to-be-marketed formulation) to healthy subjects in comparison with the drinking solution and in comparison with the trial formulation II tablet, which was administered in phase II clinical trials and also partly in phase I trials.

Timeline

Start
2009-01
Primary completion
2009-04
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Comparator BIBW 2992 MA2 Unknown 20 mg Oral

Indications

No indication recorded.