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
NCT ID: NCT01227603
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
2010-11-30
2011-07-31
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
TREATMENT
NONE
Study Groups
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Nifedipine-candesartan FDC
Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.
Nifedipine-candesartan FDC (BAY 98-7106)
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
Nifedipine and candesartan
Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.
Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Nifedipine
Each subject received one dose of nifedipine GITS 60 mg orally.
Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Candesartan
Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.
Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Interventions
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Nifedipine-candesartan FDC (BAY 98-7106)
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
Nifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Candesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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Cologne, North Rhine-Westphalia, Germany
Countries
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References
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Brendel E, Weimann B, Dietrich H, Froede C, Thomas D. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions. Int J Clin Pharmacol Ther. 2013 Sep;51(9):753-62. doi: 10.5414/CP201879.
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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2010-021966-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14027
Identifier Type: -
Identifier Source: org_study_id