Trial Condition(s):
Hypertension, Essential
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
Bayer Identifier:
14027
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations MEDA Manufacturing GmbH, ClinPharmCologne Köln, Germany, 51063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single dose study to compare the pharmacokinetics as well as safety and tolerability of a novel fixed dose combination of nifedipine GITS and candesartan, the loose combination of both and the single components alone and to investigate the bioequivalence between the fixed dose and the loose combination in healthy male volunteers under fasting conditions in an open label, randomized, 4-way-crossover design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
4
Primary Outcome
- CmaxMaximum drug concentration in plasma after dose administration for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- AUC(0-tn)AUC from time 0 to the last data point for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
Secondary Outcome
- AUCArea under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- Cmax,normMaximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- AUCnormArea under the curve divided by dose per kg body weight for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- AUC(0-48)AUC from time 0 to time 48 h for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- tmaxTime to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- t½Half-life associated with the terminal slope for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- MRTMean residence time for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- CL/fTotal body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartanTimeframe: Within 48 hours after each treatment
- Number of participants with adverse eventsTimeframe: Approximately 3.5 months
Additional Information
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