Bioequivalence of two aceclofenac tablet formulations after a single oral dose to healthy male Korean volunteers.
A bioequivalence study of aceclofenac tablets (test formulation: Dong-A, reference formulation: Airtal) was conducted in 16 healthy male Korean volunteers who received each medicine at a dose of 100 mg in a 2 x 2 crossover study. There was a one-week washout period between the doses. Plasma concentrations of aceclofenac were monitored by high-performance liquid chromatography over a period of 24 hours after the administration. AUCinf (the area under the plasma concentration-time curve from time zero to time infinity) was calculated by the linear-log trapezoidal method. Cmax (maximum plasma drug concentration) and tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCinf and Cmax, and non-transformed tmax. There were no significant differences between the medications in AUCinf and Cmax. The point estimates and 90% confidence intervals for AUCinf (parametric) and Cmax (parametric) were 1.04 (0.93 to approximately 1.17) and 0.99 (0.91 to approximately 1.08), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration Guidelines. The corresponding value for tmax was 0.75 (0.00 to approximately 1.00). Moreover, the modified Pitman-Morgan's adjusted F-test indicated that the bioavailabilities of aceclofenac in the 2 medications were comparable regarding intra- and interindividual variability. Therefore, these results indicate that the 2 medications of aceclofenac are bioequivalent and, thus, may be prescribed interchangeably.
College of Pharmacy, Seoul National University, Korea.
Y G
YG
Kim
Y J
YJ
Lee
H J
HJ
Kim
S D
SD
Lee
J W
JW
Kwon
W B
WB
Kim
C K
CK
Shim
M G
MG
Lee
D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D004008:Diclofenac / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D004008:Diclofenac; C056498:aceclofenac