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KMID : 0369820110410030191
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Jorunal of Korean Pharmaceutical Sciences
2011 Volume.41 No. 3 p.191 ~ p.196
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Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers
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Park Jun-sung
Myung Ja-Hye
Wang Hun-Sik
Koo Ja-Seong
Cho Won-Kyung
Cha Kwang-Ho
Park Hee-Jun
Kim Min-Soo
Kim Jeong-Soo
Hwang Sung-Joo
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Abstract
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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 AUC0-12h, Cmax, Tmax and T1/2 were 676.6±223.4 ng·h·mL-1, 177.4±34.2 ng·mL-1, and 0.8±0.4 and 3.5±2.1, respectively, for the test formulations, and 640.7±186.6 ng·h·mL-1, 193.0±64.5 ng·mL-1, and 0.9±0.4 and 2.7±0.9, respectively, for the reference formulation. Both primary target parameters AUC0-12h and Cmax were log-transformed and tested parametrically by analysis of variance
(ANOVA). 90% confidence intervals of AUC0-12h and Cmax 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.
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KEYWORD
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Zolpidem tartrate, HPLC, Pharmacokinetics, Bioequivalence, Assay validation
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