Comparative Bioavailability Study of Two Controlled-Release Pentoxifylline Tablet Preparations

Abstract

The bioavailability of a generic preparation of pentoxifylline sustained-release (SR) tablet was evaluated in comparison with a proprietary product (Trental 400®). For the study, 12 healthy male volunteers participated; the study was conducted according to a randomized, two-way crossover design. The bioavailability was compared using the parameters total area under the plasma level-time curve AUC_0−∞, peak plasma concentration C_max, and time to reach peak plasma concentration T_max. No statistically significant difference was observed between the values of the two products in all three parameters. The 90% confidence interval for the ratio of the logarithmic transformed AUC_0−∞ values of the generic pentoxifylline over those of Trental 400 was found to lie between 0.83 and 1.00, while that of the parameter C_max was between 0.91 and 1.29. In addition, elimination half-life t_1/2 and apparent volume of distribution V_d were calculated. There was no statistically significant difference between the t_1/2V_d values obtained from the data of the two preparations.

Key Words:

• Bioavailability
• Controlled release
• Pentoxifylline