[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of oxazepam tablets in healthy Chinese adult participants under fasting/fed conditions
主要试验目的:
考察单次口服(空腹/餐后)15mg受试制剂奥沙西泮片和参比制剂奥沙西泮片,在中国成年健康参与者体内的药代动力学特征,初步评估空腹/餐后条件下分别口服两种制剂的生物等效性。
次要试验目的:
评价受试制剂和参比制剂单次口服15mg(空腹/餐后)在中国成年健康参与者中的安全性。
[Translation] Main purpose of the study:
To investigate the pharmacokinetic characteristics of a single oral dose (fasting/after meals) of 15 mg of the test preparation oxazepam tablets and the reference preparation oxazepam tablets in healthy adult Chinese participants, and to preliminarily evaluate the bioequivalence of the two preparations under fasting/after meals conditions.
Secondary purpose of the study:
To evaluate the safety of a single oral dose of 15 mg (fasting/after meals) of the test preparation and the reference preparation in healthy adult Chinese participants.