Evaluation of the bioequivalence and pharmacokinetics of two tablet formulations of isosorbide-5-mononitrate after single oral administration in healthy volunteers.
The pharmacokinetic parameters of two oral formulations of 20 mg tablets of isosorbide-5-mononitrate (CAS 16051-77-7, Dilavenil as test and another commercially available preparation as reference) were compared in an open-label, randomized, single oral dose, two-period cross-over design in 20 healthy volunteers under fasting conditions. Plasma concentrations of isosorbide-5-mononitrate were measured by a validated gas chromatographic assay. The parametric 90% confidence intervals of the geometric mean values of the test/reference ratios were 101.2% to 108.5% (point estimate: 104.7%) for AUC0-variation of, 101.6% to 110.7% (point estimate: 106.2%) for AUC0-t, and 98.1% to 115.5% (point estimate: 106.1%) for Cmax, within the acceptance criteria for bioequivalence (80%-125%). Tmax values were analyzed by the nonparametric Wilcoxon test and the difference was not statistically significant. Therefore, it is concluded that the test and reference isosorbide-5-mononitrate formulations are bioequivalent for both the extent and the rate of absorption.
Niopas
Ioannis
I
Department of Pharmacy, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece. niopas@pharm.auth.gr
Daftsios
Athanasios C
AC
Nikolaidis
Nicolaos
N
D000328:Adult; D019540:Area Under Curve; D002849:Chromatography, Gas; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000493:pharmacokinetics*; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*
D013607:Tablets; D014665:Vasodilator Agents; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate