[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of doxycycline hydrochloride tablets (0.1 g) in healthy Chinese subjects under fasting and fed conditions
按有关生物等效性试验的规定,选择Pfizer Japan Inc.为持证商的盐酸多西环素片(商品名:Vibramycin,规格:100mg(按C22H24N2O8计))为参比制剂,对华中药业股份有限公司生产并提供的受试制剂盐酸多西环素片(规格:0.1g)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂盐酸多西环素片(规格:0.1g)和参比制剂盐酸多西环素片(商品名:Vibramycin,规格:100mg(按C22H24N2O8计))的安全性。
[Translation] According to the relevant provisions of bioequivalence test, doxycycline hydrochloride tablets (trade name: Vibramycin, specification: 100mg (calculated as C22H24N2O8)) of Pfizer Japan Inc. as the licensee were selected as the reference preparation, and the test preparation doxycycline hydrochloride tablets (specification: 0.1g) produced and provided by Huazhong Pharmaceutical Co., Ltd. were subjected to human bioequivalence test for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary study purpose: To observe the safety of oral administration of the test preparation doxycycline hydrochloride tablets (specification: 0.1g) and the reference preparation doxycycline hydrochloride tablets (trade name: Vibramycin, specification: 100mg (calculated as C22H24N2O8)) by healthy volunteers.