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18.97.14.91
18.97.14.91
SCOPUS
프레탈 정 ( 시로스타졸 50mg ) 에 대한 로사졸 정의 생물학적 동등성
Bioequivalence of Losazol Tablet to Pletaal Tablet ( Cilostazol 50mg )
김수진(Soo Jin Kim), 임동구(Dong Koo Lim), 오인준(In Joon Oh), 조행남(Haeng Nam Cho), 서순팔(Soon Pal Suh), 이용복(Yong Bok Lee)
UCI I410-ECN-0102-2008-510-001525307

Bioequivalence of two cilostazol tablets, the Pletaal^(TM) (Korea Otsuka Pharmaceutical Co., Ltd.) and the Losazol^(TM) (Kyoung Dong Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age 20∼28 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 50 ㎎ of cilostazol were orally administered, blood was taken at predetermined time intervals and the concentration of cilostazol 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 3.14%, 10.0% and 7.35%, respectively. The powers (1-β) for C_(max), T_(max) and AUC_t were 89.67%, 80.97% and 83.87%, respectively. Detectable differences (Δ) and confidence intervals were all less than 20% except T_(max), but confidence interval of T_(max), was also less than 20% at the significance level(α) of 0.1, All of these parameters met the criteria of KFDA for bioequivalence, indicating that Losazol^(TM) tablet is bioequivalent to Pletaal^(TM) tablet.

[자료제공 : 네이버학술정보]
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