[Translation] Single-center, randomized, open-label, two-formulation, single-dose, two-cycle, double-crossover fasting/postprandial bioequivalence trial of minocycline hydrochloride capsules in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂盐酸米诺环素胶囊(持证商:广州仁恒制药有限公司)与参比制剂盐酸米诺环素胶囊(持证商:Pfizer Japan Inc.,商品名:MINOMYCIN®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。次要目的:观察受试制剂盐酸米诺环素胶囊和参比制剂盐酸米诺环素胶囊在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, compare the oral administration of the test preparation minocycline hydrochloride capsules (license holder: Guangzhou Yanheng Pharmaceutical Co., Ltd.) and the reference preparation in the fasting/postprandial state. Pharmacokinetic behavior of minocycline hydrochloride capsules (licensee: Pfizer Japan Inc., trade name: MINOMYCIN®) in healthy subjects to evaluate the bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation minocycline hydrochloride capsules and the reference preparation minocycline hydrochloride capsules in healthy subjects.