Current investigation was aimed to study bioequivalence of two felodipine formulations and pharmacokinetic studies of human plasma were conducted. Pharmacokinetic parameters such as Cmax, Tmax, AUC(0-t), AUC(0-∞), Keli and t½ were calculated and the blood plasma level data of the reference product and the test product were compared. Plasma onset of drug for both was 0.5 hr. The Cmax for reference product was 10.72 1.15 ng/ml with Tmax of 3.17 0.70 hr. The Cmax and Tmax of the Felodipine test product were 10.70 1.17 ng/ml and 3.75 0.44 hr. The AUC(0-t) for reference product was 216.24 33.66 ng.h / ml and 196.50 30.28 ng.h / ml for the test product. The Keli for the reference product was 0.03 0.00 h-1 and 0.03 0.03 h-1for the test product. The t½ of reference product was 24.22 0.88 h and for test product it was found to be 25.01 0.99 h. The AUC(0-∞) for the reference product was 240.87±34.56 ng.h/ml and for test product it was found to be 221.26±33.05 ng.h/ml. No subject developed any adverse experience during the study protocol. Based on the above observations after oral administration of tablets containing 10 mg of Felodipine it could conclude that the test product is bioequivalent of that of the reference product of felodipine and both are well tolerated. Further the results of the present investigation shown that there is scope for further studies on felodipine metabolism with respect to efficacy and pharmacokinetics.
