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.
Clinical pharmacology
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
49
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
Unnamed facility
Berlin, State of Berlin, Germany
Cmax
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Time frame: within 48 hours after each dosing
AUC(0-tlast)
Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan
Time frame: within 48 hours after each dosing
AUC
Area under the curve from time 0 to infinity after single dose for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
Cmax,norm
Dose normalized Cmax for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
AUCnorm
AUC normalized for dose and body weight for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
AUC(0-48)
Area under the plasma concentration-time curve from time zero to 48h for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
Tmax
The time of the maximum concentration for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
t1/2
Half-life for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
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MRT
The mean residence time for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
CL/F
Oral plasma clearances for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
Number of participants with adverse events
Time frame: Approximately 3-7 weeks per subject