Bioequivalence Study of the Generic Meloxicam (Melox®) Compared with the Innovator Mobic®.

Abstract

The bioequivalence of two brands of 7.5 mg meloxicam were demonstrated in healthy volunteers after a single oral dose in a randomized 2-period crossover study. The reference and the test formulation were administered to fasted male volunteers, thereafter, the blood samples were collected at specific time interval from 0-96 h. The washout period was 2 weeks. The plasma meloxicam concentrations were determined by HPLC. The pharmacokinetic parameters obtained after non-compartmental analysis were statistically evaluated for bioequivalence using ANOV A. RESULT; The median Tmax (h) of the two products were similar ( 4.5 VS 4.0), however, the range of Tmax (h) for the reference product (2 .0-10.0) was more variable than that of the test (4.0-10.0). Bioequivalence analysis showed that the Cmax and the AUCo-∞ did not differ significantly. The point estimator (90%CI) for the ratio Test/Reference of log transformed data of the AUCo-∞ and Cmax were 0.97 (0.90-1.06) and 0.95 (0.84-1.08), respectively. These values were within the bioequivalence range of 0.80-1.25, thus our study demonstrated the bioequivalence of the test and the reference preparations.