[Translation] A single-dose, randomized, open-label, two-period, two-sequence, double-crossover bioequivalence study of trazodone hydrochloride tablets in healthy subjects under fasting and fed conditions
主要目的:研究空腹和餐后状态下单次口服受试制剂盐酸曲唑酮片与参比制剂盐酸曲唑酮片(规格:100mg)在健康成年受试者体内的药代动力学,评价两种制剂的生物等效性。
次要目的:评价健康受试者空腹和餐后单次口服受试制剂(T)盐酸曲唑酮片和参比制剂(R)盐酸曲唑酮片后的安全性。
[Translation] Primary objective: To study the pharmacokinetics of the test preparation trazodone hydrochloride tablets and the reference preparation trazodone hydrochloride tablets (specification: 100 mg) in healthy adult subjects after a single oral administration in fasting and postprandial states, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation (T) trazodone hydrochloride tablets and the reference preparation (R) trazodone hydrochloride tablets after a single oral administration in healthy subjects after fasting and postprandial states.