[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of Procaterol Hydrochloride Tablets in healthy Chinese adult participants under fasting and fed conditions
主要研究目的:考察单次口服(空腹和餐后)受试制剂盐酸丙卡特罗片和参比制剂盐酸丙卡特罗片,在中国成年健康参与者体内的药代动力学特征,评估空腹和餐后条件下分别口服两种制剂的生物等效性。
次要研究目的:评价受试制剂和参比制剂单次口服(空腹和餐后)在中国成年健康参与者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of the test preparation Procaterol Hydrochloride Tablets and the reference preparation Procaterol Hydrochloride Tablets in healthy adult Chinese participants after a single oral administration (fasting and after meals), and to evaluate the bioequivalence of the two preparations after oral administration under fasting and after meals.
Secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy adult Chinese participants after a single oral administration (fasting and after meals).