NCT01227603

Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions

Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-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, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs

Conditions

• Hypertension, Essential

Interventions

Type	Name	Description
DRUG	Nifedipine-candesartan FDC (BAY 98-7106)	Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
DRUG	Nifedipine GITS (Adalat LA, BAYA1040)	Single oral dose of 1 tablet of nifedipine GITS 60 mg
DRUG	Candesartan (Atacand)	Single oral dose of 32 mg (2 x 16 mg tablet) candesartan

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2010-10-25
• Last updated: 2015-12-10

Locations

1 site across 1 country: Germany