Hypertension, Essential
Conditions
Keywords
Bioequivalence, Nifedipine, Candesartan, FDC
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
Interventions
DRUGNifedipine-candesartan FDC (BAY 98-7106)
Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
DRUGNifedipine GITS (Adalat LA, BAYA1040)
Single oral dose of 1 tablet of nifedipine GITS 60 mg
DRUGCandesartan (Atacand)
Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| MRT | Within 48 hours after each treatment | Mean residence time 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 | — |
| t½ | Within 48 hours after each treatment | Half-life associated with the terminal slope 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 |
Countries
Germany
Outcome results
None listed