[Translation] A single-dose, randomized, open-label, two-cycle, two-sequence, self-crossover design bioequivalence trial of trazodone hydrochloride tablets in healthy study participants under fasting and postprandial conditions
主要研究目的
研究空腹和餐后状态下单次口服受试制剂盐酸曲唑酮片(规格:50mg,浙江和沐康医药科技有限公司研发)与参比制剂盐酸曲唑酮片(商品名:RESLIN®,规格:50mg,持证商:オルガノン株式会社)在健康成年研究参与者体内的药代动力学,评价两制剂生物等效性。
次要研究目的
评价健康研究参与者空腹和餐后状态下单次口服受试制剂(T)盐酸曲唑酮片和参比制剂(R)盐酸曲唑酮片(RESLIN®)后的安全性。
[Translation] Main research purpose
Study the single oral administration of the test preparation Trazodone Hydrochloride Tablets (specification: 50 mg, developed by Zhejiang Hemukang Pharmaceutical Technology Co., Ltd.) and the reference preparation Trazodone Hydrochloride Tablets (trade name: RESLIN®, specifications) in the fasting and postprandial state : 50mg, license holder: Alono Co., Ltd.) in vivo pharmacokinetics of healthy adult study participants to evaluate the bioequivalence of the two preparations.
Secondary research purpose
To evaluate the safety of healthy study participants following single oral administration of test formulation (T) trazodone hydrochloride tablets and reference formulation (R) trazodone hydrochloride tablets (RESLIN®) in the fasting and postprandial states.