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

Bayer49 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension, Essential

Interventions

Nifedipine-candesartan FDC (BAY 98-7106)DRUG

Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan

Nifedipine GITS (Adalat LA, BAYA1040)DRUG

Single oral dose of 1 tablet of nifedipine GITS 60 mg

Candesartan (Atacand)DRUG

Single oral dose of 32 mg (2 x 16 mg tablet) candesartan

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subject * Age: 18 to 45 years (inclusive) at the first screening / examination visit * Ethnicity: Caucasian * Body mass index (BMI): \>/=18 and \</=29,9 kg/m² Exclusion Criteria: * Systolic blood pressure below 120 or above 145 mmHg * Diastolic blood pressure above 95 mmHg * Heart rate below 45 or above 95 beats / min * Clinically relevant findings in the physical examination * Suspicion of drug or alcohol abuse * Regular daily consumption of more than 1 L of xanthin-containing beverages * Intake of foods or beverages containing grapefruit within 4 weeks before the pre-study examination

Locations (1)

Unnamed facility

Cologne, North Rhine-Westphalia, Germany