Bioequivalence of diclofenac injection formulations assessed in Korean males
Zhu, X.; Shin, W.G.
International Journal of Clinical Pharmacology and Therapeutics 43(11): 546-550
2005
ISSN/ISBN: 0946-1965 PMID: 16300171 Document Number: 588216
A bioequivalence study of diclofenac injection (test formulation (diclofenac potassium): HANA, reference formulation (diclofenac sodium): Shinpoong) was conducted in 18 healthy male Korean volunteers who received each medicine at a dose of 75 mg in a 2 x 2 crossover study. There was a one-week washout period between the doses. Plasma concentrations of diclofenac were monitored by high-performance liquid chromatography over a period of 24 hours after the i.m. injection. AUC(0-24) (the area under the plasma concentration-time curve from time 0-24 hours) was calculated by the linear-log trapezoidal method. C-max (maximum plasma drug 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(0-24) and C-max, and non-transformed t(max). There were no significant differences between the medications in AUC(0-24) and C-max. The point estimates and 90% confidence intervals for AUC(0-24) (parametric) and C-max (parametric) were 0.973 (0.8971 to 1.0557) and 0.993 (0.9452-1.0451), 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 t(max) was 0.75 (0.00 to 1.00). Moreover, the modified Pitman-Morgan's adjusted F-test indicated that the bioavailabilities of diclofenac in the two medications were comparable regarding intra- and interindividual variability. Therefore, these results indicate that the two medications of diclofenac are bioequivalent and, thus, may be prescribed interchangeably.