CompletedPhase 1

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

Germany49 participantsStarted 2010-11

Plain-language 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

Who can participate

Age range18 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cmax

Timeframe: Within 48 hours after each treatment

AUC(0-tn)

Timeframe: Within 48 hours after each treatment

Trial details

NCT IDNCT01227603

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-03

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