Bioequivalence of Metoprolol Tartrate Tablets in healthy volunteers

Abstract

Abstract: AIM: To study the bioequivalence of domestic and imported Metoprolol Tartrate Tablets in Chinese healthy volunteers.METHODS: According to the rule published by SFDA , the serum concentration of 20 selected volunteers among 18 to 40 years old was determined by HPLC-fluorescence detection after giving domestic and imported Metoprolol Tartrate Tablets 0.1g , and the pharmacokinetic parameters were calculated by DAS software.RESULTS: The method of HPLC-fluorescence detection to study the pharmakokinetics of Metoprolol Tartrate was sensitive , reliable , accurate and reasonable.The main pharmakokinetics parameters of domestic and imported Metoprolol Tartrate Tablets were Tmax:1.11 ±0.36 h and 1.39 ±0.65 h respectively;Cmax:269.20±87.15 μg·L-1 and 262.03 ±75.52 μg·L-1 respectively;AUC0 -12h:1088.91 ±510.52 μg·L-1·h and1098.29 ±5 55.14 μg·L-1·h respectively.The relative bioavailability of domestic Metoprolol Tartrate Tablets was 100.09 %.CONCLUSION: The domestic and imported Metoprolol Tartrate Tablets was bioequivalents.

Key words: Metoprolol Tartrate Tablets, HPLC-fluorescence detection, bioequivalence

CLC Number:

WANG Jing, FU Liang-qing, GUAN Yong-biao<, FANG Yi<, LIU Ze-yuan. Bioequivalence of Metoprolol Tartrate Tablets in healthy volunteers[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(9): 1043-1047.

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Bioequivalence of Metoprolol Tartrate Tablets in healthy volunteers

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