[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover bioequivalence study of doxycycline hydrochloride tablets in healthy Chinese participants
主要目的:以安徽杰玺医药有限公司生产的盐酸多西环素片(100mg(按C22H24N2O8计))为受试制剂,以Pfizer Japan Inc持有的盐酸多西环素片(商品名:Vibramycin,规格:100mg(按C22H24N2O8计))为参比制剂,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口服给药的生物等效性。
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)在中国健康成年参与者中的安全性。
[Translation] Primary Objective: To conduct a bioequivalence study using doxycycline hydrochloride tablets (100 mg (calculated as C₂₂H₂₄N₂O₄) manufactured by Anhui Jiexi Pharmaceutical Co., Ltd. as the test formulation and doxycycline hydrochloride tablets (trade name: Vibramycin, strength: 100 mg (calculated as C₂₂H₂₄N₂O₄) manufactured by Pfizer Japan Inc. as the reference formulation. The bioequivalence of the two formulations after single oral administration under fasting and fed conditions was compared.
Secondary Objective: To evaluate the safety of a single oral dose of the test formulation (doxycycline hydrochloride tablets, T) and the reference formulation (Vibramycin, R) in healthy Chinese adult participants.