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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Candesartan; Candesartan cilexetil; Nifedipine

Criteria

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 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