Pharmacokinetic and Bioequivalence Study of Meloxicam Tablets in Healthy Male Subjects

 

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Abstract

Meloxicam (CAS 71125-38-7), a non-steroidal anti-inflammatory drug (NSAID), is used for the treatment of osteoarthritis and rheumatic arthritis. In the present study, two different oral meioxlcam formulations (Melcam^© 15 mg tablets as test preparation and tablets of a reference preparation) were investigated in 24 healthy male subjects in order to prove bioequivalence between both preparations. A single 15 mg oral dose was administered according to an open, randomised, two-period cross-over design in the fasted state. Blood samples for the determination of meloxicam plasma concentrations were collected at pre-defined time points up to 96 h following drug administration. A wash-out period of 7–8 days separated both treatment periods. Meloxlcam plasma concentrations were determined by means of a validated HPLC method with UV-detection. Maximum plasma concentrations (C_max) of 1,146.9 ng/ml (test) and 1,064.8 ng/ml (reference) were achieved. Areas under the plasma concentration-time curve (AUC_0→∞)of 34,499.0 ng · h/ml (test) and 33,784.3 ng · h/ml (reference) were determined. The results showed nearly identical rate and extent of drug absorption. Also further pharmacokinetic parameters were well comparable. Thus, t_max showed values of 5.00 h for both test and reference. The plasma elimination half-life (t_1/2) was 18.29 h (test) und 18.94 h (reference). Both primary target parameters C_max and AUC_0→∞ were tested parametrically by analysis of variance (ANOVA) and the 90% confidence intervals were between 99.46%-l05.24% (AUC_0→∞ and 103.37%-112.46% (C_max). Bioequivalence between test and reference preparation was demonstrated since for both parameters AUC and C_max the 90% confidence intervals of the T/R ratios of logarithmically transformed data were in the generally accepted range of 80%-125%.