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

Bayer

Status and phase: Completed; Phase 1

Conditions: Hypertension, Essential

Treatments: Drug: Nifedipine-candesartan FDC (BAY 98-7106); Drug: Nifedipine GITS (Adalat LA, BAYA1040); Drug: Candesartan (Atacand)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227603

2010-021966-31 (EudraCT Number)

14027

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 4 patient groups

Nifedipine-candesartan FDC

Experimental group

Description:

Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.

Treatment:

Drug: Nifedipine-candesartan FDC (BAY 98-7106)

Nifedipine and candesartan

Active Comparator group

Description:

Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.

Treatment:

Drug: Nifedipine GITS (Adalat LA, BAYA1040)

Drug: Candesartan (Atacand)

Nifedipine

Active Comparator group

Description:

Each subject received one dose of nifedipine GITS 60 mg orally.

Treatment:

Drug: Nifedipine GITS (Adalat LA, BAYA1040)

Candesartan

Active Comparator group

Description:

Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.

Treatment:

Drug: Candesartan (Atacand)