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首页> 外文期刊>Current therapeutic research, clinical and experimental. >Bioequivalence of 2 Azithromycin Capsule Formulations: A Randomized, Single-Dose, Open-Label, 2-Period Crossover Study in Healthy Male Pakistani Volunteers
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Bioequivalence of 2 Azithromycin Capsule Formulations: A Randomized, Single-Dose, Open-Label, 2-Period Crossover Study in Healthy Male Pakistani Volunteers

机译：2种阿奇霉素胶囊制剂的生物等效性：健康男性巴基斯坦志愿者中的一项随机，单剂量，开放标签，2期交叉研究

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摘要

BACKGROUND: Approximately 68 brands of azithromycin capsule formulations are available in Pakistan; however, published data on their bioequivalence in the Pakistani population are not available.Objective: Upon instructions from and approval of the Ministry of Health, Pakistan, this study was designed to evaluate the bioequivalence of a locally manufactured azithromycin capsule formulation with a reference formulation from a multinational manufacturer. This study compared dissolution profiles, relative bio-availability, and other pharmacokinetic parameters of the 2 formulations.METHODS: A single oral 500-mg dose of the 2 formulations was administered to 12 healthy adult Pakistani male volunteers under fasting conditions in a randomized, open-label, 2-period crossover study. The trial included collection of blood samples over 48 hours and a 2-week washout period. Azithromycin serum concentrations were quantified using a validated RP-HPLC/ultraviolet (UV) detection method. These results were used to determine the intended pharmacokinetic parameters. As mandated by the US Food and Drug Administration and the European Medicine Agency, the test and reference formulations were considered bioequivalent if the 90% CIs of the geometric mean ratios for the log-transformed values of their pharmacokinetic parameters were within the predetermined range of 0.8 to 1.25.
机译：背景：在巴基斯坦，大约有68个品牌的阿奇霉素胶囊制剂可用。目的：根据巴基斯坦卫生部的指示和批准，本研究旨在评估巴基斯坦当地生产的阿奇霉素胶囊制剂与参考制剂的生物等效性。跨国制造商。这项研究比较了2种配方的溶出度，相对生物利用度和其他药代动力学参数方法：在禁食条件下，随机，开放地向12名巴基斯坦健康成年男性志愿者单次口服500 mg剂量的2种配方标记的2期交叉研究。该试验包括在48小时内和2周的清除期中收集血液样本。使用经过验证的RP-HPLC /紫外线（UV）检测方法对阿奇霉素血清浓度进行定量。这些结果用于确定预期的药代动力学参数。根据美国食品药物管理局和欧洲医学局的要求，如果其药代动力学参数的对数转换值的几何平均比的90％CIs在0.8的预定范围内，则认为测试和参考制剂具有生物等效性。至1.25。

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