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KMID : 0941819990090010044
Korean Journal of Clinical Pharmacy
1999 Volume.9 No. 1 p.44 ~ p.48
Bioequivalence Evaluation of Aceclofenac Tablets




Abstract
The bioequivalence of two aceclofenac tablets was evaluated in 14 normal volunteers (age 21sim29 yrs) following oral administration. The test product was ¡¯¡¯Apental tablet¡¯¡¯ made by Asia Pharmaceutical Co. and the reference was ¡¯¡¯Airtal tablet¡¯¡¯ made by Daewoong Pharmaceutical Co. After one tablet containing 100 mg aceclofenac was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was quantitated with an HPLC method. AUC, C_{max};and;T_{max} were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, C_{max};and;T_{max} between two products were 4.23%,;2.15%;and;0%, respectively. The powers for AUC,;C_{max};and;T_{max};were;>90%,;>90%;and;85.8%, respectively. Confidence intervals were within pm20% for three parameters. All of these parameters met the criteria of KFDA for bioequivalence, indicating that ¡¯¡¯Apental tablet¡¯¡¯ is bioequivalent to ¡¯¡¯Airtal tablet¡¯¡¯
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