Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Hypertension, Essential
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 comb...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01227603
Start Date
November 1 2010
End Date
July 1 2011
Last Update
December 10 2015
Active Locations (1)
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1
Cologne, North Rhine-Westphalia, Germany, 51063