[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study was conducted to evaluate the bioequivalence of the test product, Procaterol HCl Granules (strength: 50 μg), and the reference product, Procaterol HCl Dry Syrup (Meptin®) (strength: 0.005% (g/g)), in healthy adult participants under fasting and fed conditions.
主要试验目的:研究空腹和餐后状态下单次口服受试制剂盐酸丙卡特罗颗粒(规格:50 μg,广州一品红制药有限公司生产)与参比制剂盐酸丙卡特罗干糖浆(Meptin®,规格:0.005% (g/g);大塚制药株式会社生产)在健康参与者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂盐酸丙卡特罗颗粒(规格:50 μg)和参比制剂盐酸丙卡特罗干糖浆(Meptin®)(规格:0.005% (g/g))在健康参与者中的安全性。
[Translation] Main purpose of the test: To study the single oral administration of the test preparation Procaterol Hydrochloride Granules (specification: 50 μg, produced by Guangzhou Yipinhong Pharmaceutical Co., Ltd.) and the reference preparation Procaterol Hydrochloride Dry Syrup (Meptin®, Specification: 0.005% (g/g); manufactured by Otsuka Pharmaceutical Co., Ltd.) in healthy participants to evaluate the bioequivalence of the two oral formulations in the fasting and postprandial states.
Secondary trial purpose: To study the effects of the test preparation Procaterol Hydrochloride Granules (specification: 50 μg) and the reference preparation Procaterol Hydrochloride Dry Syrup (Meptin®) (Specification: 0.005% (g/g)) in healthy participants Security.