[Translation] A single-center, open-label, randomized, single-dose, four-period, fully repeated, two-sequence, crossover bioequivalence study of paroxetine hydrochloride enteric-coated sustained-release tablets in healthy adult subjects under fasting and fed conditions
主要研究目的:评估受试制剂盐酸帕罗西汀肠溶缓释片25 mg与参比制剂盐酸帕罗西汀肠溶缓释片(商品名:赛乐特®CR)25 mg在健康成年受试者体内的药代动力学,评价空腹/餐后状态下口服两种制剂的生物等效性。
次要研究目的:评价受试制剂盐酸帕罗西汀肠溶缓释片与参比制剂盐酸帕罗西汀肠溶缓释片(商品名:赛乐特®CR)在健康成年受试者中的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetics of the test preparation paroxetine hydrochloride enteric-coated sustained-release tablets 25 mg and the reference preparation paroxetine hydrochloride enteric-coated sustained-release tablets (trade name: Seroxetine®CR) 25 mg in healthy adult subjects, and to evaluate the oral bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose of the study is to evaluate the safety of the test preparation paroxetine hydrochloride enteric-coated sustained-release tablets and the reference preparation paroxetine hydrochloride enteric-coated sustained-release tablets (trade name: Seroxetine®CR) in healthy adult subjects.