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KMID : 0941819970070020073
Korean Journal of Clinical Pharmacy
1997 Volume.7 No. 2 p.73 ~ p.80
Bioequivalence of Loxoprofen Tablets
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Abstract
The bioequivalence of two loxoprofen tablets between the Loxonin^{TM} (Dong Hwa Pharmaceutical Co., Ltd.) and the Lokpen^{TM} (Dong Il Pharmaceutical Co., Ltd.) was evaluated. 12 normal male volunteers (age 21sim27 years old) were divided into two groups and a randomized cross-over study was employed. After one tablet containing 60 mg of loxoprofen sodium anhydrous was orally administered, blood was taken at predetermined time intervals and the concentration of loxoprofen in serum was determined with an HPLC method using UV/VIS detector. The pharmacokinetic parameters (C_{max},;T_{max}, and AUC_t) were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in C_{max},;T_{max}, and AUC_t between two tablets were 1.13%,;0%,;and;0.69%, respectively The powers (1-{beta}) for C_{max},;T_{max}, and AUC_t were 84.88%,;88.61%,;and;84.81%, respectively Detectable differences (delta) and confidence intervals were all less than 20%. All of these parameters met the criteria of KFDA for bioequivalence, indicating that Lokpen^{TM} tablet is bioequivalent to Loxonin^{TM} tablet.
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