[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of trazodone hydrochloride extended-release tablets in healthy subjects under fasting and fed conditions
主要目的
比较空腹和餐后给药条件下,沈阳欣瑞制药有限公司生产的盐酸曲唑酮缓释片(150mg)与Az.Chim.Riun.Angelini Francesco Acraf S.P.A.持证的盐酸曲唑酮缓释片(150mg,商品名:曲特恪®TRITTICO®)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,沈阳欣瑞制药有限公司生产的盐酸曲唑酮缓释片(150mg)与Az.Chim.Riun.Angelini Francesco Acraf S.P.A.持证的盐酸曲唑酮缓释片(150mg,商品名:曲特恪®TRITTICO®)的安全性。
[Translation] Main purpose
To compare the differences in the extent and rate of absorption of trazodone hydrochloride sustained-release tablets (150 mg) produced by Shenyang Xinrui Pharmaceutical Co., Ltd. and trazodone hydrochloride sustained-release tablets (150 mg, trade name: TRITTICO®) certified by Az.Chim.Riun.Angelini Francesco Acraf S.P.A. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary purpose
To evaluate the safety of trazodone hydrochloride sustained-release tablets (150 mg) produced by Shenyang Xinrui Pharmaceutical Co., Ltd. and trazodone hydrochloride sustained-release tablets (150 mg, trade name: TRITTICO®) certified by Az.Chim.Riun.Angelini Francesco Acraf S.P.A. under fasting and postprandial administration conditions.