Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed

Hypertension, Essential Clinical Trial

Official title:
Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan and the Loose Combination of Both Components and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Subjects Under Fed Conditions in an Open Label, Randomized, 2-way-crossover Design

Status Completed

Clinical Trial Summary

Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.

Clinical Trial Description

Clinical pharmacology ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01350609
Study type	Interventional
Source	Bayer
Contact
Status	Completed
Phase	Phase 1
Start date	April 2011
Completion date	September 2011

View Details

See also
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