Pharmacokinetic and bioequivalence study of meloxicam tablets in healthy male subjects


Gschwend M. H. , Erenmemisoglu A. , Martin W., Tamur U., Kanzik I., Hincal A. A.

ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH, cilt.57, ss.264-268, 2007 (SCI İndekslerine Giren Dergi) identifier identifier identifier

  • Cilt numarası: 57 Konu: 5
  • Basım Tarihi: 2007
  • Dergi Adı: ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH
  • Sayfa Sayıları: ss.264-268

Özet

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 meloxicam formulations (Melcam (R) 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. Meloxicam 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/nil (reference) were achieved. Areas under the plasma concentration-time curve (AUC(0-infinity)) of 34,499.0 ng - h/nd (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-infinity) were tested parametrically by analysis of variance (ANOVA) and the 90% confidence intervals were between 99.46%-105.24% (AUC(0-infinity)) 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 %.