[Bioavailability of new nifedipine preparations in man. 2. Bioequivalence of nifedipine in the form of soft gelatin capsules]

Abstract

In a randomized, two-fold cross-over design 12 healthy volunteers received a normal-release 10 mg nifedipine soft gelatine capsule (Pidilat or a marketed product, respectively). The quantitative determination of the drug in plasma was achieved by gas chromatography up to 24 h p.a. Some important pharmacokinetic parameters and the relative bioavailabilities of the preparations were calculated and subsequently compared statistically: statistically significant differences between the preparations could not be found. Mean peak plasma concentrations of 121.2 +/- 47.3 and 104.5 +/- 32.9 ng/ml were reached approximately 0.5 h p.a. Both plasma level curves were practically identical, with the exception of the obtained absolute peak plasma concentrations. The known strong inter- and intraindividual variations of the plasma levels were found to be less pronounced in this study.