[Translation] A single-center, randomized, open-label, single-dose, two-agent, two-cycle crossover human bioequivalence study of flupentixol and melitracen tablets in healthy Chinese subjects
主要研究目的:以植恩生物技术股份有限公司生产的氟哌噻吨美利曲辛片(每片含氟哌噻吨 0.5mg 和美利曲辛 10mg)为受试制剂(T),以H.Lundbeck A/S 生产的氟哌噻吨美利曲辛片(每片含氟哌噻吨 0.5mg 和美利曲辛 10mg,黛力新®)为参比制剂(R),按有关生物等效性试验的规定进行生物等效性试验。
次要研究目的:观察受试制剂和参比制剂氟哌噻吨美利曲辛片在健康受试者中的安全性。
[Translation] Main research purpose: The flupentixol and melitracen tablets (each tablet contains 0.5 mg of flupentixol and 10 mg of melitracen) produced by Zein Biotechnology Co., Ltd. were used as the test preparation (T), and H. The flupentixol and melitracen tablets (each tablet containing flupentixol 0.5mg and melitracen 10mg, Delixin®) produced by Lundbeck A/S is the reference preparation (R), according to the relevant bioequivalence A bioequivalence test is carried out according to the provisions of the test.
Secondary research objectives: To observe the safety of the test preparation and reference preparation Flupentixol and Melitracen Tablets in healthy subjects.