[Translation] A single-center, randomized, open-label, two-formulation, fasting, single-dose, two-sequence, two-period, double-crossover design human bioequivalence study was conducted in healthy trial participants for doxycycline hydrochloride tablets (0.1 g) produced by Shaanxi Xiyue Pharmaceutical Co., Ltd. and doxycycline hydrochloride tablets (trade name: Vibramycin®, strength: 100 mg) produced by Pfizer Japan Inc.
以陕西西岳制药有限公司持有的盐酸多西环素片(规格:0.1 g)为受试制剂,Pfizer Japan Inc.持证的盐酸多西环素片(商品名:Vibramycin®,规格:100 mg)为参比制剂,考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性;并评价盐酸多西环素片在健康试验参与者中的安全性。
[Translation] Using doxycycline hydrochloride tablets (0.1 g) from Shaanxi Xiyue Pharmaceutical Co., Ltd. as the test formulation and doxycycline hydrochloride tablets (Vibramycin®, 100 mg) from Pfizer Japan Inc. as the reference formulation, the pharmacokinetic parameters and relative bioavailability of the two formulations under fasting single-dose administration were investigated to evaluate whether the two formulations were bioequivalent; and the safety of doxycycline hydrochloride tablets in healthy trial participants was evaluated.