两种头孢地诺酯产品在健康志愿者血清和尿液数据中的比较生物利用度。

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Clinical and Experimental Pharmacology and Physiology Pub Date : 2004-07-01 DOI:10.1111/j.1440-1681.2004.04012.x

S Otoom, M Hasan, N Najib

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引用次数: 6

摘要

1. 本研究的目的是评估两种头孢地诺酯产品的生物等效性，即500毫克胶囊形式的Ultracef(参考产品)(由美国新泽西州普林斯顿的百时美施贵宝实验室生产)和500毫克胶囊形式的Roxil(测试产品)(由沙特阿拉伯Tabuk Pharmaceutical Manufacturing公司生产)。2. 这项研究是根据美国食品和药物管理局(FDA)的指导方针(http://www.fda.gov/cder)对24名健康男性受试者进行的。两种产品均以单剂量(1 x 500 mg胶囊)口服，间隔1周洗脱期。口服给药后，采集血液和尿液样本，并使用灵敏和特异的高效液相色谱法分析头孢地诺的浓度。3.两种产品在不同时间的头孢地洛辛的平均浓度-时间分布或累积尿排泄量方面没有统计学上的显著差异。同样，反映药物吸收速度和程度的药代动力学参数也没有统计学意义。通过计算Roxil/Ultracef在10 h和无限时间内的曲线下面积(AUC)比来评估药物的相对吸收程度为0.94,90%置信限(CL)为0.91-0.98。与血清数据一致，用药10 h后尿中累积排泄头孢地洛辛的平均比值(Roxil/Ultracef)为0.97,90% CL为0.88-1.05。AUC的CL和累积尿排泄比在FDA接受的生物等效产品限值(0.80-1.25)之内。4. 这些结果表明头孢氨苄的血清和尿液数据是一致的，并表明头孢氨苄(试验产品)和ultrtracef(参比产品)在药物吸收速度和程度上是生物等效的。

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Comparative bioavailability of two cefadroxil products using serum and urine data in healthy human volunteers.

1. The aim of the present study was to assess the bioequivalence of two cefadroxil products, namely Ultracef (a reference product) in the form of a 500 mg capsule (produced by Bristol‐Myers Squibb Laboratories, Princeton, NJ, USA) and Roxil (a test product) in the form of a 500 mg capsule (produced by Tabuk Pharmaceutical Manufacturing, Tabuk, Saudi Arabia).

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来源期刊

Clinical and Experimental Pharmacology and Physiology PHARMACOLOGY & PHARMACY-PHYSIOLOGY

自引率

0.00%

发文量

128

期刊介绍： Clinical and Experimental Pharmacology and Physiology is an international journal founded in 1974 by Mike Rand, Austin Doyle, John Coghlan and Paul Korner. Our focus is new frontiers in physiology and pharmacology, emphasizing the translation of basic research to clinical practice. We publish original articles, invited reviews and our exciting, cutting-edge Frontiers-in-Research series’.