NCT01227603View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

March 31, 2011

Study Completion Date

July 31, 2011

Conditions
Hypertension, Essential
Interventions
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

Trial Locations (1)

51063

Cologne

Sponsors

Lead Sponsor

Bayer
All Listed Sponsors
lead

Bayer

INDUSTRY