NCT01350609

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Clinical pharmacology

Conditions

• Hypertension, Essential

Interventions

Type	Name	Description
DRUG	Nifedipine/Candesartan (BAY 98-7106)	Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
DRUG	Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)	Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2011-05-10
• Last updated: 2015-12-10

Locations

1 site across 1 country: Germany