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Bioavailability Study of Two Different Verapamil Formulations
Author(s) -
Horne C.,
Stenzhorn G.,
Blume H.,
Knauf H.,
Mutschler E.
Publication year - 1992
Publication title -
archiv der pharmazie
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.468
H-Index - 61
eISSN - 1521-4184
pISSN - 0365-6233
DOI - 10.1002/ardp.19923250814
Subject(s) - bioequivalence , bioavailability , pharmacokinetics , confidence interval , pharmacology , analysis of variance , verapamil , chemistry , medicine , calcium
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‐co) , C max , t max ) were taken into account. Shortest 90% confidence intervals were calculated based on parametric (ANOVA, ANOVA log ) 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 C max . A mean relative bioavailability of 127% for the test preparation was found. Thus, bioavailability of the dragées is marked higher than bioavailability of the filmcoated tablets.