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
Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design
2 other identifiers
interventional
49
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2010
CompletedFirst Posted
Study publicly available on registry
October 25, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 10, 2015
December 1, 2015
4 months
October 22, 2010
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cmax
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Within 48 hours after each treatment
AUC(0-tn)
AUC from time 0 to the last data point for nifedipine and candesartan
Within 48 hours after each treatment
Secondary Outcomes (9)
AUC
Within 48 hours after each treatment
Cmax,norm
Within 48 hours after each treatment
AUCnorm
Within 48 hours after each treatment
AUC(0-48)
Within 48 hours after each treatment
tmax
Within 48 hours after each treatment
- +4 more secondary outcomes
Study Arms (4)
Nifedipine-candesartan FDC
EXPERIMENTALEach subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.
Nifedipine and candesartan
ACTIVE COMPARATOREach subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally.
Nifedipine
ACTIVE COMPARATOREach subject received one dose of nifedipine GITS 60 mg orally.
Candesartan
ACTIVE COMPARATOREach subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally.
Interventions
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
Single oral dose of 1 tablet of nifedipine GITS 60 mg
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Cologne, North Rhine-Westphalia, 51063, Germany
Related Publications (1)
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.
PMID: 23849325RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2010
First Posted
October 25, 2010
Study Start
November 1, 2010
Primary Completion
March 1, 2011
Study Completion
July 1, 2011
Last Updated
December 10, 2015
Record last verified: 2015-12