Bioequivalence of clopidogrel hydrogen sulfate tablets in healthy Chinese volunteers

Abstract

Abstract: AIM: To evaluate the bioequivalence of clopidogrel hydrogen sulfate tablets(Areplex and Poland) in healthy Chinese volunteers after a single dosage oral administration.METHODS: A single oral doses of 75 mg clopidogrel hydrogen sulfate tablets(test and reference) were given to 32 healthy Chinese volunteers according to an open randomized crossover design. The concentrations of clopidogrel acid(carboxylic metabolite of clopidogrel) in plasma were determined by LC-MS/MS.With the aid of DAS 2.0, the bioequivalence of the test and reference preparation were calculated by analysis of variance, tow one sided t-test.RESULTS: The pharmacokinetic parameters of the two preparations were as follow:C_max of test drug and reference drug were(1351.1±654.9)ng/mL and (1184.6±607.7) ng/mL,AUC_0-24h were (2642.0±1093.8) ng·h·mL^-1 and (2780.6±1283.1) ng·h·mL^-1,t_1/2 were (3.81±2.54)h and (4.62±2.88) h,t_max were (0.80±0.32) h and (0.95±0.63) h,respectively. The relative bioavailability of the formulation was (101.4±34.8)%.CONCLUSION: It is an accurate,sensitive,rapid and convenient method that can be applied to determine clopidogrel in human plasma. The tested preparation is bioequivalence to the reference preparation.

Key words: Clopidogrel, Clopidogrel acid, LC-MS/MS, Bioequivalence

CLC Number:

R969.1

YANG Yong-ge, ZHANG Mei, JIANG Nan, SONG Li-xue, XU Xue-ting, DI Xiao-hui, XU Lin, XU Juan,ZHAO Gang-tao. Bioequivalence of clopidogrel hydrogen sulfate tablets in healthy Chinese volunteers[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(1): 38-43.

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