Trial Condition(s):

Hypertension, Essential

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 Identifier:

14027

ClinicalTrials.gov Identifier:

NCT01227603

EudraCT Number:

2010-021966-31

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
49
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

MEDA Manufacturing GmbH, ClinPharmCologne

Köln, Germany, 51063

Status
Completed
 

Trial Design