S. E. Leucuta *, R. Capalneanu *, D.I. Postestescu *, Marcela Achirn *, Manuela Preda *, Mirela Moldovan *, A. Bodea *, Ana Rusu *
* S. E. Leucuta, R. Capalneanu, D.I. Postestescu, Marcela Achim, Manuela Preda, Mirela Moldovan, A. Bodea, Ana Rusu – Universitatea de Medicină şi Farmacie “I. Hatieganu”, Cluj-Napoca, Catedra de Tehnologie farmaceutică şi Biofarmacie, Laboratorul de Biofarmacie şi Farmacocinetică
Abstract
The aim of this study was to demonstrate the bioequivalence of two sustained formulations of nifedipine: Nifedipin (Terapia, Cluj Napoca) and Adalat (Bayer), following the oral administration of single doses of 20 mg nifedipine to 12 healthy subjects in a cross-over design. The assay of nifedipine in plasma samples was made by HPLC. The characteristic pharmacokinetic parameters were area under the curve (AUC), and half value duration (HVD), both their log ratio and 90% confidence interval being in the bioequivalence range. The same was determined for the secondary pharmacokinetic parameter, C max, but Tmax was in the 70 – 140% domain. Based on the pharmacokinetic parameters evaluated in this study, it was concluded that the studied products were bioequivalent both as amount and rate of absorption. They may actually be effective as a maintenance treatment of coronary cardiac disorders and hypertension.