/ Not yet recruitingNot Applicable 富马酸喹硫平口腔崩解片随机、开放、两制剂、单次给药、三周期、三序列、三交叉空腹/餐后生物等效性试验
[Translation] A randomized, open-label, two-dose, single-dose, three-period, three-sequence, three-crossover fasting/fed bioequivalence study of quetiapine fumarate orally disintegrating tablets
以药代动力学参数作为主要终点评价指标,分别比较空腹/餐后状态下口服受试制剂北京凯奕医药科技发展有限公司提供的富马酸喹硫平口腔崩解片与参比制剂富马酸喹硫平片(AstraZeneca UK Limited,商品名:Seroquel®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性,观察两种制剂在健康受试者中的安全性。
[Translation] Pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behaviors of the test preparation, quetiapine fumarate orally disintegrating tablets provided by Beijing Kaiyi Pharmaceutical Technology Development Co., Ltd., and the reference preparation, quetiapine fumarate tablets (AstraZeneca UK Limited, trade name: Seroquel®), in healthy subjects after oral administration in the fasting/postprandial state, to evaluate the bioequivalence of the two preparations and observe the safety of the two preparations in healthy subjects.
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