Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
NCT ID: NCT01350609
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2011-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Nifedipine/Candesartan (fixed dose)
Nifedipine/Candesartan (BAY 98-7106)
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
Nifedipine/Candesartan (loose)
Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
Interventions
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Nifedipine/Candesartan (BAY 98-7106)
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Berlin, State of Berlin, Germany
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2011-000322-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14028
Identifier Type: -
Identifier Source: org_study_id