Clinical trial NCT01227603: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Essential
Keywords: Bioequivalence
Nifedipine
Candesartan
FDC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Cmax
timeFrame: Within 48 hours after each treatment
measure: AUC(0-tn)
timeFrame: Within 48 hours after each treatment
Secondary outcomes:
measure: AUC
timeFrame: Within 48 hours after each treatment
measure: Cmax,norm
timeFrame: Within 48 hours after each treatment
measure: AUCnorm
timeFrame: Within 48 hours after each treatment
measure: AUC(0-48)
timeFrame: Within 48 hours after each treatment
measure: tmax
timeFrame: Within 48 hours after each treatment
measure: t½
timeFrame: Within 48 hours after each treatment
measure: MRT
timeFrame: Within 48 hours after each treatment
measure: CL/f
timeFrame: Within 48 hours after each treatment
measure: Number of participants with adverse events
timeFrame: Approximately 3.5 months
Other outcomes:
Locations:
city: Köln
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.