Bioequivalence of two aceclofenac tablet formulations after a single oral dose to healthy male Korean volunteers

Citation
Yg. Kim et al., Bioequivalence of two aceclofenac tablet formulations after a single oral dose to healthy male Korean volunteers, INT J CL PH, 39(2), 2001, pp. 83-88
Citations number
13
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology & Toxicology
Journal title
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
ISSN journal
0946-1965 → ACNP
Volume
39
Issue
2
Year of publication
2001
Pages
83 - 88
Database
ISI
SICI code
0946-1965(200102)39:2<83:BOTATF>2.0.ZU;2-W
Abstract
A bioequivalence study of aceclofenac tablets (test formulation: Dong-A, re ference formulation: Airtal) was conducted in 16 healthy male Korean volunt eers who received each medicine at a dose of 100 mg in a 2 x 2 crossover st udy. There was a one-week washout period between the doses. Plasma concentr ations of aceclofenac were monitored by high-performance liquid chromatogra phy over a period of 24 hours after the administration. AUC(inf)(the area u nder the plasma concentration-time curve from time zero to time infinity) w as calculated by the linear-log trapezoidal method. C-max (maximum plasma d rug concentration) and t(max) (time to reach C-max) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC(inf) and C-max, and non-transformed There, were no significant differences between the medications in AUC(inf) and C-m ax. The point estimates and 90% confidence intervals for AUC(inf) (parametr ic) and C-max (parametric) were 1.04 (0.93 similar to 1.17) and 0.99 (0.91 similar to 1.08), respectively, satisfying the bioequivalence criteria of t he European Committee for Proprietary Medicinal Products and the US Food an d Drug Administration Guidelines. The corresponding value for t(max) was 0. 75 (0.00 similar to 1.00). Moreover, the modified Pitman-Morgan's adjusted F-test indicated that the bioavailabilities of aceclofenac in the 2 medicat ions were comparable regarding intra- and interindividual variability. Ther efore, these results indicate that the 2 medications of aceclofenac are bio equivalent and, thus, may be prescribed interchangeably.