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Aceclofenac, 2-[(2’’,6’’-dichlorphenyl)amino]phenylacetoxiacetic acid, is a new nonsteroidal anti-inflammatory drug that belongs to the family of phenylacetic acids. It shows good tolerance and potent analgesic/antiinflammatory properties, and acts on cartilaginous chondriocytes, stimulating their repair mechanism. The purpose of the present study was to evaluate the bioequivalence of two aceclofenac products, Airtal^{TM} tablet (Daewoong Pharmaceutical Co.) and Acer^{TM} capsule (Kyungdong Pharmaceutical Co.), according to the guideliner of Korea Food and Drug Administration (KFDA). The aceclofenac release from the two aceclofenac products in vitro was tested using KP VII Apparatus II method at pH 7.8 dissolution media. Sixteen normal male volunteers, 23.13pm2.03 years in age and 66.33pm7.08 kg in body weight, were divided into two groups and a randomized 2times2 cross-over study was employed. After one tablet or capsule containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentrations of aceclofenac in serum were determined using HPLC with UV detector. The dissolution profiles of the two aceclofenac products were very similar at pH 7.8 dissolution media. The pharmacokinetic parameters such as AUC_t,;C_{max};and;T_max were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t,;C_{max};and;T_{max} between two products were 6.50%,;-1.06%;and;11.96% respectively, when calculated against the Airtal^{TM} tablet. The powers (1-beta);for;AUC_t,;C_{max};were;89.82%;and;82.84%, respectively. Minimum detectable differences (Delta);a;alpha=0.05;and;1-beta=0.8 were less than 20%;(e.g.,;17.51%;and;19.30%;for;AUC_t,;C_{max}, ). The 90% confidence intervals were within pm20%;(e.g.,;-3.73%sim16.73%;and;-12.34%sim10.22%;for;AUC_t,;C_{max},;respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Acer^{TM} capsule is bioequivalent to Airtal^{TM} tablet.
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