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에어탈 정 ( 아세클로페낙 100mg ) 에 대한 세니탈 정의 생물학적 동등성
김수진(Soo Jin Kim),오인준(In Joon Oh),박행순(Haeng Soon Park),서세민(Se Min Seo),서순팔(Soon Pal Suh),이용복(Yong Sok Lee) 한국약제학회 1998 Journal of Pharmaceutical Investigation Vol.28 No.4
Bioequivalence of two aceclofenac tablets, the Airtal^(TM) (Daewoong Pharmaceutical Co., Ltd.) and the Senital^(TM) (Hana Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age 20∼29 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 100 ㎎ of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method using UV 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 3.69%, 2.44% and 0.51%, respectively. The powers (1-β) for C_(max), T_(max) and AUC_t were 87.85%, 98.70% and more than 99%, respectively. Detectable differences (Δ) and confidence intervals were all less than ±20%. All of these parameters met the criteria of KFDA for bioequivalence, indicating that Senital^(TM) tablet is bioequivalent to Airtal^(TM) tablet.