Hypertension, Essential
Conditions
Keywords
essential hypertension, blood pressure, nifedipine, candesartan, FDC
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
Interventions
DRUGNifedipine/Candesartan (BAY 98-7106)
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
DRUGNifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | within 48 hours after each dosing | Maximum drug concentration in plasma after dose administration for nifedipine and candesartan |
| AUC(0-tlast) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCnorm | Within 48 hours after each dosing | AUC normalized for dose and body weight for nifedipine and candesartan |
| AUC(0-48) | Within 48 hours after each dosing | Area under the plasma concentration-time curve from time zero to 48h for nifedipine and candesartan |
| Tmax | Within 48 hours after each dosing | The time of the maximum concentration for nifedipine and candesartan |
| AUC | Within 48 hours after each dosing | Area under the curve from time 0 to infinity after single dose for nifedipine and candesartan |
| MRT | Within 48 hours after each dosing | The mean residence time for nifedipine and candesartan |
| CL/F | Within 48 hours after each dosing | Oral plasma clearances for nifedipine and candesartan |
| Number of participants with adverse events | Approximately 3-7 weeks per subject | — |
| t1/2 | Within 48 hours after each dosing | Half-life for nifedipine and candesartan |
| Cmax,norm | Within 48 hours after each dosing | Dose normalized Cmax for nifedipine and candesartan |
Countries
Germany
Outcome results
None listed