NCT01350609CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 49
- Primary Endpoint
- AUC(0-tlast)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Nifedipine/Candesartan (fixed dose)
Experimental
Intervention: Nifedipine/Candesartan (BAY 98-7106) (Drug)
Nifedipine/Candesartan (loose)
Active Comparator
Intervention: Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) (Drug)
Outcomes
Primary Outcomes
AUC(0-tlast)
Time Frame: within 48 hours after each dosing
Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan
Cmax
Time Frame: within 48 hours after each dosing
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Secondary Outcomes
- Cmax,norm(Within 48 hours after each dosing)
- AUC(0-48)(Within 48 hours after each dosing)
- Tmax(Within 48 hours after each dosing)
- t1/2(Within 48 hours after each dosing)
- MRT(Within 48 hours after each dosing)
- CL/F(Within 48 hours after each dosing)
- Number of participants with adverse events(Approximately 3-7 weeks per subject)
- AUCnorm(Within 48 hours after each dosing)
- AUC(Within 48 hours after each dosing)
Investigators
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