[Translation] A single-center, randomized, open-label, single-dose, two-dose, four-period, completely repeated crossover bioequivalence study of buspirone hydrochloride tablets under fasting and fed conditions was conducted in healthy Chinese adult participants.
主要研究目的:
考察单次口服(空腹/餐后)5mg受试制剂盐酸丁螺环酮片和参比制剂盐酸丁螺环酮片,在中国成年健康参与者体内的药代动力学特征,评估空腹与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5mg(空腹/餐后)在中国成年健康参与者中的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of a single oral dose (fasting/postprandial) of 5 mg of the test preparation buspirone hydrochloride tablets and the reference preparation buspirone hydrochloride tablets in healthy adult Chinese participants, and to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions.
Secondary study objectives:
To evaluate the safety of a single oral dose of 5 mg (fasting/postprandial) of the test preparation and the reference preparation in healthy adult Chinese participants.