Trial Condition(s):

Hypertension, Essential

Pivotal bioequivalence FDC nifedipine / candesartan vs. loose combination of single components, fed

Bayer Identifier:

14028

ClinicalTrials.gov Identifier:

NCT01350609

EudraCT Number:

2011-000322-29

Study Completed

Trial Purpose

Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.

Inclusion Criteria
- The informed consent form must be signed before any study specific tests or procedures are done
 - Confirmation of the subject’s health insurance coverage prior to the first screening visit
 - Healthy male subject
 - Ethnicity: Caucasian
 - Age: 18 to 45 years (inclusive) at the first screening visit
 - Body mass index (BMI) above or equal 18, and below or equal 29.9 kg / m²
 - Ability to understand and follow study-related instructions
Exclusion Criteria
- 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 2 weeks prior to the first study drug administration (the same applies to pomelos and St. John’s Wort)
 - Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)
 -- examples for CYP3A inhibitors: erythromycin, inhibitors of human HIV protease (e.g. ritonavir, saquinavir), amiodarone, diltiazem, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodon, cimetidine;
 -- examples for CYP3A inducers: rifampicin, carbamazepin, phenytoin, phenobarbital, or products containing St. John’s Wort;
 - Systolic blood pressure below 116 or above 145 mmHg (after at least 15 min supine)
 - At the first screening visit
 -- Diastolic blood pressure above 95 mmHg (after at least 15 min supine)
 -- Heart rate below 45 or above 95 beats / min (after at least 15 min supine) at the first screening visit
 -- Clinically relevant findings in the physical examination
 -- Positive urine drug screening or alcohol breath test
 - Exclusion periods from other studies or simultaneous participation in other clinical studies

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

Bayer Pharma AG

Berlin, Germany, 13353

Status
Completed
 

Trial Design