Gulati R, Tripathi C D, Chandra D
Department of Pharmacology, Maulana Azad Medical College, Bahadurshah Zafar Marg, New Delhi-110 002.
J Assoc Physicians India. 2000 Jun;48(6):606-8.
To compare the bioequivalence of two brands of azithromycin capsules in healthy male volunteers for regulatory purpose.
A single oral dose of 500 mg of either test (Panacea Biotec Ltd.) or reference (Pfizer India Ltd.) preparation of azithromycin was administered to 12 volunteers in double blind randomised cross over fashion. Serum levels of azithromycin were analysed using microbiological assay. The pharmacokinetic parameters studied were Cmax, Tmax, AUC, t1/2, Ke, CL and MRT. In vitro dissolution tests were conducted for both the preparations and compared with in vivo absorption.
The mean peak serum azithromycin concentration of 0.516 +/- 0.008 microgram/ml was observed at 2.33 +/- 0.22 h with test brand and was similar to that of reference brand with Cmax of 0.494 +/- 0.011 microgram/ml at 2.71 +/- 0.26 h. The statistical difference between all the other paharmacokinetic parameters were insignificant.
Both the brands of azithromycin can be considered to be bioequivalent on the basis of results obtained.
为监管目的比较两种品牌阿奇霉素胶囊在健康男性志愿者中的生物等效性。
以双盲随机交叉方式给12名志愿者单次口服500mg试验制剂（帕那恰生物技术有限公司）或参比制剂（辉瑞印度有限公司）的阿奇霉素。采用微生物测定法分析阿奇霉素的血清水平。研究的药代动力学参数为Cmax、Tmax、AUC、t1/2、Ke、CL和MRT。对两种制剂进行体外溶出试验，并与体内吸收情况进行比较。
试验品牌在2.33±0.22小时观察到阿奇霉素血清平均峰浓度为0.516±0.008微克/毫升，与参比品牌相似，参比品牌在2.71±0.26小时的Cmax为0.494±0.011微克/毫升。所有其他药代动力学参数之间的统计学差异不显著。
根据所获结果，两种品牌的阿奇霉素可被认为具有生物等效性。
