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서지반출
Bioequivalence Assessment of Triamcinolone Tablets in Healthy Male Human Volunteers
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  • Bioequivalence Assessment of Triamcinolone Tablets in Healthy Male Human Volunteers
  • Bioequivalence Assessment of Triamcinolone Tablets in Healthy Male Human Volunteers
저자명
Pyo. Hee-Soo,Jang. Moon-Sun,Chung. Youn-Bok,Kwon. Oh-Seung
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
권/호정보
2002년|10권 3호|pp.180-185 (6 pages)
발행정보
한국응용약물학회
파일정보
정기간행물|ENG|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang Triamcinolone$ extregistered$ vs. Wyeth Korea Ledercoat$ extregistered$) was assessed in healthy male volunteers after oral administration of 16mg triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0longrightarrowlast}$, $AUC_{0longrightarrowinf}$ and $T_{1/2, eta} were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to Korea Food and Drug Administration Guideline. The analysis of variance did not show any significant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang triamcinlone$ extregistered$ tablet is bioequivalent to the Wyeth Korea Ledercoat$ extregistered$ tablet.