[Translation] Bioequivalence study of flupentixol-melitracen tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服氟哌噻吨美利曲辛片受试制剂(规格:每片含氟哌噻吨0.5mg和美利曲辛10mg,申办者:广东健信制药股份有限公司)和参比制剂(商品名:黛力新®,规格:氟哌噻吨0.5mg和美利曲辛10mg/片,持证商:H.Lundbeck A/S)后的药代动力学特点和生物等效性。
次要研究目的
研究氟哌噻吨美利曲辛片受试制剂(规格:每片含氟哌噻吨0.5mg和美利曲辛10mg)和参比制剂(商品名:黛力新®,规格:氟哌噻吨0.5mg和美利曲辛10mg/片)在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of flupentixol-melitracen tablets (specification: each tablet contains 0.5 mg flupentixol and 10 mg melitracen, applicant: Guangdong Jianxin Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Deanxit®, specification: 0.5 mg flupentixol and 10 mg melitracen/tablet, licensee: H. Lundbeck A/S) in healthy Chinese adult subjects after a single oral dose under fasting and postprandial conditions.
Secondary study objectives
To study the safety of the test formulation of flupentixol-melitracen tablets (specification: each tablet contains 0.5 mg flupentixol and 10 mg melitracen) and the reference formulation (trade name: Deanxit®, specification: 0.5 mg flupentixol and 10 mg melitracen/tablet) in healthy Chinese adult subjects.
100 Clinical Results associated with Guangdong Jianxin Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Guangdong Jianxin Pharmaceutical Co., Ltd.