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目的:研究两种盐酸白马多缓释片的药代动力学及相对生物利用度。方法:随机交叉试验设计,健康志愿者口服单剂量和多剂量盐酸曲马多缓释片,气相色谱法测定血清中盐曲马多的浓度。结果:两药AUCo—t、Tmax、Cmax等药代动力学参数均无显著性差异。结论:两药具有生物等效性。
OBJECTIVE: To study the pharmacokinetics and relative bioavailability of two kinds of hydrochloric acid and white multi-sustained release tablets. Methods: Randomized crossover design was conducted. The healthy volunteers were given single and multiple doses of tramadol hydrochloride tablets and the concentrations of tramadol in serum were determined by gas chromatography. Results: The two drugs AUCo-t, Tmax, Cmax pharmacokinetic parameters such as no significant difference. Conclusion: The two drugs are bioequivalent.