[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design of minocycline hydrochloride capsules in healthy subjects under fasting and fed conditions
本试验旨在研究单次空腹和餐后口服成都瑞尔医药科技有限公司研制、杭州民生药业股份有限公司生产的盐酸米诺环素胶囊(100 mg)的药代动力学特征;以Pfizer Japan Inc.持证、ファイザー株式会社生产的盐酸米诺环素胶囊(MINOMYCIN®/ミノマイシン®,100 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to study the pharmacokinetic characteristics of minocycline hydrochloride capsules (100 mg) developed by Chengdu Ruier Pharmaceutical Technology Co., Ltd. and produced by Hangzhou Minsheng Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; minocycline hydrochloride capsules (MINOMYCIN®/ミノマイシン®, 100 mg) certified by Pfizer Japan Inc. and produced by ファイザー Co., Ltd. were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.