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Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers
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  • Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers
  • Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers
저자명
Park. Jun-Sung,Myung. Ja-Hye,Wang. Hun-Sik,Koo. Ja-Seong,Cho. Won-Kyung,Cha. Kwang-Ho,Park. Hee-Jun,Kim. Min-So,Kim. Jeong-Soo,H
간행물명
Journal of pharmaceutical investigation
권/호정보
2011년|41권 3호|pp.191-196 (6 pages)
발행정보
한국약제학회
파일정보
정기간행물|ENG|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{pm}223.4$ $ng{cdot}h{cdot}mL^{-1}$, $177.4{pm}34.2$ $ng{cdot}mL^{-1}$, and $0.8{pm}0.4$ and $3.5{pm}2.1$, respectively, for the test formulations, and $640.7{pm}186.6$ $ng{cdot}h{cdot}mL^{-1}$, $193.0{pm}64.5$ $ng{cdot}mL^{-1}$, and $0.9{pm}0.4$ and $2.7{pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.