니페디핀 서방정(니페디핀 33mg)의 생물학적 동등성

Abstract

Nifedipine, one of calcium channel antagonists, has been used for the treatment of mild to moderate hypertention, angina pectoris, Raynaud’s phenomenon and various other cardiovascular diseases. Because of its short biological half-life, several sustained-release (SR) formulations of nifedipine have been developed and used clinically. The bioequivalence of the two nifedipine SR preparations was evaluated according to the guidelines of KFDA. The test product was Hanmi Nifedipine SR tablet made by Hanmi Pharm. Co. and the reference was Adalat Oros tablet made by Bayer Korea. Thirty healthy male subjects were divided into two groups and a randomized 2×2 cross-over study was employed. After one SR tablet containing 33 mg of nifedipine was orally administered, blood sample was taken at predetermined time intervals and the concentrations of nifedipine in plasma were determined using a validated HPLC method with UV detector. Two pharmacokinetic parameters, AUCt and Cmax, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of the AUCt and the Cmax were log 0.81~log 1.19 and log 0.84~log 1.13, respectively. These values were within the acceptable bioequivalence intervals from log 0.8 to log 1.25 in KFDA guidelines. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Nifedipine SR tablet is bioequivalent to Adalat Oros tablet.