Bioavailability study of two different verapamil formulations.
Relative bioavailability and bioequivalence of two oral verapamil preparations were investigated (dosage 80 mg, film-coated tablets as reference, dragées as test formulation). The clinical study was performed in a 2-period-cross-over design with 16 male healthy volunteers (mean age 28.8 +/- 3 years). The active metabolite norverapamil was included in the investigation. To assess bioequivalence several pharmacokinetic characteristics (i.e. AUC(o-oo), Cmax, tmax) were taken into account. Shortest 90% confidence intervals were calculated based on parametric (ANOVA, ANOVAlog) and non-parametric (Wilcoxon, Mann-Whitney) statistical tests. A positive decision for bioequivalence was accepted if the confidence intervals did not exceed the limits of 80-120% for AUC and 70-130% for Cmax. A mean relative bioavailability of 127% for the test preparation was found. Thus, bioavailability of the dragées is marked higher than bioavailability of the film-coated tablets.
Horne
C
C
Pharmakologisches Institut für Naturwissenschaftler, University, Frankfurt/M., FRG.
Stenzhorn
G
G
Blume
H
H
Knauf
H
H
Mutschler
E
E
D000328:Adult; D001682:Biological Availability; D003692:Delayed-Action Preparations; D006801:Humans; D008297:Male; D013607:Tablets; D014700:Verapamil / Q000008:administration & dosage / Q000493:pharmacokinetics*
D003692:Delayed-Action Preparations; D013607:Tablets; D014700:Verapamil