BIOEQUIVALENCE STUDY OF GENERIC PENTOXIFYLLINE

ABSTRACT

The bioequivalence of two oral formulations of pentoxifylline were evaluated. The two products were administered as a single oral dose in a randomized two-way crossover design to 12 healthy Thai male volunteers. The washout period between each treatment was 1 week. After drug administration, serial blood samples were collected over a period of 30 hours. Plasma pentoxifylline concentrations were measured by HPLC with UV detection. The pharmacokinetic parameters were analyzed by non-compart-mental analysis. RESULTS: The maximum pentoxifylline concentrations (Cmax, ng/mL), median time to reach the Cmax (Tmax, hr) for the test and the reference were 225.5 (range 374.9-111.1), 1.0 (0.75-2.0) and 218.4 (390.4-133.7), 0.88 (0.5-1.5), respectively. Analysis of variance for bioequivalence was carried out using logarithmi-cally transformed AUC 0-ฅ and Cmax. The mean (90% CI) of the AUC 0-ฅ and Cmax ratios for the Test Reference were 0.99 (0.81-1.22) and 1.02 (0.91-1.15), respectively. These values were within the bioequivalence range of 0.80-1.25, thus, our study demonstrated the bioequivalence of the test and reference. Chiang Mai Med Bull 2003;42(1)7-16.