drugset / Trial / NCT00884442

Nifedipine Bioavailability Study With Oral Single Doses Under Fasting and Fed Conditions

NCT00884442

Phase 1 Completed 28 enrolled SocraTec R&D GmbH SocraMetrics GmbH · collab
RandomizedCrossoverOpen-label

Summary

The present study will be performed to investigate and to compare the in-vivo performance of the two investigational products Gen-nifedipine extended release, (previously referred to as Gen-Nifedipine XL (Genpharm ULC, Canada)) and Nifedipine(Bayer Healthcare AG manufactured as Adalat® XL®, Adalat® LA, Adalat® Crono, Adalat® OROS) by comparing their pharmacokinetic parameters after oral single dose administrations in the fasted and fed state.

Timeline

Start
2009-04
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nifedipine Other / unclassified 60 mg Oral

Indications

No indication recorded.