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ACTA Pharmaceutica Sciencia
2010 , Vol 52 , Num 1
BIOAVAILABILITY AND PHARAMCOTHERAPEUTICS OF NIFEDIPINE IN HUMAN AFTER SINGLE ORAL DOSE ADMINISTRATION
Department of Pharmacy, Faculty of Pharmacy and Alternative Medicines, The Islamia University of Bahawalpur, Bahawalpur, Pakistan
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To determine bioavailability and pharmaco-therapeutics of nifedipine in human after single oral dose administration. Six male healthy human subjects, participating in this complete crossover study, received 2 × 10-mg nifedipine capsules of reference and test batches. After drug administration, blood samples of the subjects were collected up to six hours and analyzed using HPLC. Mean AUC was observed as 1939.54 ng.h.ml-1 and l820.19 ng.h.ml-1 for Test and Reference batches respectively. Mean peak plasma concentrations were found to be 220.83 ng.ml-1 and 210.33 ng.ml-1 while time to peak plasma level were 1.25 h and 1.58 h for treatment and control batches respectively. Complete bioequivalence metrics are determined and thus this study may serve as a model for further bioequivalence studies in the country. The pharmacodynamic parameters such as blood pressure and pulse rate of the participating subjects were monitored throughout the study which, when examined for correlation with the drug blood levels, revealed a high degree of similarity in physiologic ranges and thus confirmed the earlier studies.
Keywords :
NIFEDIPINE, BIOEQUIVALENCE, PHARMACODYNAMIC PARAMETERS