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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.
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Objective To determine the contents of isoflavones in the form of aglycones (daidzein, genistein) as well as respective β-glycosides (daidzin, genistin), and their presence in UHT and fresh soymilk available in Amphur Muang, Chiang Mai, Thailand. Methods Ten samples of ultra high temparature (UHT) processed soymilk and 20 samples of fresh soymilk were randomly purchased from different zones. Isoflavone contents in each sample were determined by high performance liquid chromatography. Results Isoflavone contents in both soy beverages ranged from approximately 10-70 mg/serving, and β-glycosides dominated. The median concentration of aglycones in fresh soymilk was significantly greater than that in UHT soymilk, whereas, the median values of β-glycoside concentrations, total isoflavone concentrations and the total isoflavones per serving (mg) in UHT soymilk were significantly greater than those in fresh soymilk. Nonetheless, the median value of maximal absorbable isoflavones per serving (in the unit of μmol) did not significantly differ between the two soy beverages. Conclusion Isoflavone contents in both soy beverages varied substantially. Although the proportions and concentrations of aglycones and β-glycosides as well as the total isoflavones per serving (mg) were significantly different between both soy beverages, the maximal absorbable isoflavones per serving (μmol) did not significantly differ. Chiang Mai Med Bull 2004;43(4):151-161.
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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.
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To determine the bioequivalence of two formulations of recombinant human erythropoietin alpha (epoetin alpha 4000-IU), the two formulations; Renogen® and the Reference, Eprex® were administered to 18 healthy Thai male volunteers as a single subcutaneous dose according to a randomized two-way crossover design. Serial blood samples were collected over a period of 96 hours. The pharmacokinetic parameters were analyzed by noncompartmental analysis, and bioequivalence analysis (ANOVA) was carried out using logarithmically transformed data of the AUC, Cmax and untransformed Tmax. The elimination half-life of the test product (28.7 h) and the reference (31.1 h) were comparable. The median Tmax of the test product (12.0 h, range 4-15 h) was slightly slower than that of the reference (11.0 h, range 8-15 h). The ANOVA showed no statistically significant differences between the AUC and Cmax values or between the test and the reference preparations. The mean (90% CI) for the ratios Test/Reference for AUC0-t, AUC0-∞ and Cmax were 1.03 (0.97-1.10), 1.01 (0.96-1.06) and 0.99 (0.90-1.08), respectively, within the bioequivalence range of 0.80-1.25. The study concluded that the test product is bioequivalent to the reference.