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
- Conditions
- Hypertension, Essential
- Interventions
- Drug: Nifedipine GITS (Adalat LA, BAYA1040)Drug: Candesartan (Atacand)Drug: Nifedipine-candesartan FDC (BAY 98-7106)
- Registration Number
- NCT01227603
- Lead Sponsor
- Bayer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nifedipine and candesartan Nifedipine GITS (Adalat LA, BAYA1040) Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally. Nifedipine Nifedipine GITS (Adalat LA, BAYA1040) Each subject received one dose of nifedipine GITS 60 mg orally. Candesartan Candesartan (Atacand) Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally. Nifedipine and candesartan Candesartan (Atacand) Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally. Nifedipine-candesartan FDC Nifedipine-candesartan FDC (BAY 98-7106) Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally.
- Primary Outcome Measures
Name Time Method Cmax Within 48 hours after each treatment Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
AUC(0-tn) Within 48 hours after each treatment AUC from time 0 to the last data point for nifedipine and candesartan
- Secondary Outcome Measures
Name Time Method MRT Within 48 hours after each treatment Mean residence time for nifedipine and candesartan
AUC Within 48 hours after each treatment Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan
Cmax,norm Within 48 hours after each treatment Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan
AUCnorm Within 48 hours after each treatment Area under the curve divided by dose per kg body weight for nifedipine and candesartan
AUC(0-48) Within 48 hours after each treatment AUC from time 0 to time 48 h for nifedipine and candesartan
tmax Within 48 hours after each treatment Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan
t½ Within 48 hours after each treatment Half-life associated with the terminal slope for nifedipine and candesartan
CL/f Within 48 hours after each treatment Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan
Number of participants with adverse events Approximately 3.5 months