Tehran University of Medical Sciences
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Davood Beiki

Comparative bioavailability of two tablet formulation of dipyridamole in healthy male volunteers


Authors: Beiki D, Amini M, Dowlatabadi R, Pirali M,
Keywords: Dipyridamole; Comparative bioavailability; Pharmacokinetic parameters; Bioequivalent
Iran J Pharm Res , Vol.2, No.4, 2003,Page:213-216

The bioavailability of two dipyridamol tablet formulations of (Dipyridamole from Tolidaru and Persantin from Boehringer) was compared in 14 healthy male volunteers who received a single dose of 25 mg of the test (T) and the reference (R) products in a randomized balanced 2-way crossover design. Plasma samples were obtained over a 16 h interval and dipyridamole concentrations determined by HPLC with ultraviolet detection. The maximum plasma concentration (Cmax), area under the plasma concentration time curve up to the last measurable concentration (AUC0-t), as well as infinity (AUC0-¥), and the absorption rate (Cmax/AUC0-¥) were analyzed statistically under the assumption of a multiplicative model. The time to maximum concentration (Tmax) was analyzed assuming an additive model. The parametric confidence intervals (90%) of the mean values of the pharmacokinetic characteristics for T/R ratio were in each case well within the bioequivalence acceptable range of 80-125%. The test formulation was found bioequivalent to the reference formulation by the Schuirmann’s two one-sided t tests and by Wilcoxon Mann Whitney two one-sided tests procedure. Therefore, the 2 formulations were considered to be equivalent.