Clinical trial NCT01350609: Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
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 and the Loose Combination of Both Components and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Subjects Under Fed Conditions in an Open Label, Randomized, 2-way-crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Essential
Keywords: essential hypertension, blood pressure, nifedipine, candesartan, FDC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-05-10
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: Clinical pharmacology

Eligibility criteria: 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

Primary outcomes:
measure: Cmax
timeFrame: within 48 hours after each dosing
measure: AUC(0-tlast)
timeFrame: within 48 hours after each dosing
Secondary outcomes:
measure: AUC
timeFrame: Within 48 hours after each dosing
measure: Cmax,norm
timeFrame: Within 48 hours after each dosing
measure: AUCnorm
timeFrame: Within 48 hours after each dosing
measure: AUC(0-48)
timeFrame: Within 48 hours after each dosing
measure: Tmax
timeFrame: Within 48 hours after each dosing
measure: t1/2
timeFrame: Within 48 hours after each dosing
measure: MRT
timeFrame: Within 48 hours after each dosing
measure: CL/F
timeFrame: Within 48 hours after each dosing
measure: Number of participants with adverse events
timeFrame: Approximately 3-7 weeks per subject
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: