RESUMEN
Objective To evaluate the relative bioavialability of two oral formulations of 15-mg of meloxicam tablets. Methods The study was conducted as an open label, two-way, crossover design with a washout period of 2-weeks. Twelve healthy male volunteers were given either one tablet of the test formulation or the same dose of the innovator after fasting. Blood samples were collected at 96 h postdose. The plasma was separated and the concentrations of meloxicam were determined by the HPLC method. Results The mean Cmax (ng/mL) was 1,509.80 and 1,379.94, while the mean AUC 0-∞ (ng.h/ mL) was 62,770.29 and 57,752.81 for the test and reference, respectively. The average Tmax (h) and half-life (h) of the test (6.25, 25.44) were slightly longer than those of the reference (5.33, 23.42). The relative bioavailability (%) with respect to the Cmax and AUC 0-∞ was 109.60 and 108.18, while, the mean (90% CI) after logarithmical (ln) transformation was 1.09 (0.97- 1.22) and 1.07 (1.02-1.13), respectively. No significant differences in pharmacokinetic parameters between the two formulations were found. Therefore, the study concluded that the bioavailability of the two meloxicam formulations are bioequivalent in terms of rate and extent of absorption. Chiang Mai Med Bull 2005;44(3):91-100.
RESUMEN
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.