- 프레탈 정(실로스타졸 100 mg)에 대한 엘지실로스타졸 정의 생물학적 동등성
- ㆍ 저자명
- 조혜영,임동구,신상철,문재동,이용복,Cho. Hea-Young,Lim. Dong-Koo,Shin. Sang-Chul,Moon. Jai-Dong,Lee. Yong-Bok
- ㆍ 간행물명
- 한국임상약학회지
- ㆍ 권/호정보
- 2001년|11권 1호|pp.7-12 (6 pages)
- ㆍ 발행정보
- 한국임상약학회
- ㆍ 파일정보
- 정기간행물| PDF텍스트
- ㆍ 주제분야
- 기타
Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platalet cyclic AMP phosphodiesterase. Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co.) and the LG $Cilostazol^{TM}$ (LG Chemical Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ($20sim29$ years old) were randomly divided into two groups and a randomized $2 imes2$ cross-over study was employed. After oral administration of $Pletaal^{TM}$ or LG $Cilostazol^{TM}$ tablet (100 mg cilostazol), blood samples were taken at predetermined time intervals and the serum cilostazol concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters $(AUC_t,;C_{max};and;T_{max})$ were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in AUCt, C_{max} and Tmax between two tablets based on the $Pletaal^{TM}$ tablet were $-5.39\%,;2.32\%;and;4.26\%$, respectively. The powers (1-${eta}$) for $AUC_t,;C_{max};and;T_{max};were;83.81\%,;96.02\%;and;91.04%$, respectively. Minimum detectable differences ($Delta$) and $90\%$ confidence intervals were all less than $pm20\%$. All these parameters met the criteria of KFDA for bioequivalence, indicating that LG $Cilostazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM}$ tablet.