[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of doxycycline hydrochloride tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的:以中国健康受试者为对象,考察开封制药(集团)有限公司生产的盐酸多西环素片(受试制剂0.1 g/片)与Pfizer Japan Inc.持证的盐酸多西环素片(Vibramycin,参比制剂100 mg/片)进行生物等效性试验,比较两种制剂在空腹和餐后条件下单次给药的生物等效性。
次要目的:评估单剂口服受试制剂(盐酸多西环素片,T)和参比制剂(Vibramycin,R)在中国健康成年受试者中的安全性。
[Translation] Primary Objective: To conduct a bioequivalence study of doxycycline hydrochloride tablets (test formulation, 0.1 g/tablet) manufactured by Kaifeng Pharmaceutical (Group) Co., Ltd. and Pfizer Japan Inc.'s certified doxycycline hydrochloride tablets (Vibramycin, reference formulation, 100 mg/tablet) in healthy Chinese subjects. The bioequivalence of the two formulations was compared after single administration under fasting and fed conditions.
Secondary Objective: To evaluate the safety of single oral doses of the test formulation (doxycycline hydrochloride tablets, T) and the reference formulation (Vibramycin, R) in healthy Chinese adult subjects.