Chongqing Zein Pharmaceutical Co. Ltd.

Primary study objective: To conduct bioequivalence test in accordance with the relevant provisions of bioequivalence test, using flupentixol-melitracen tablets (containing 0.5 mg flupentixol and 10 mg melitracen per tablet) produced by Zhien Biotechnology Co., Ltd. as the test preparation (T) and flupentixol-melitracen tablets (containing 0.5 mg flupentixol and 10 mg melitracen per tablet, Delexin®) produced by H.Lundbeck A/S as the reference preparation (R). Secondary study objective: To observe the safety of the test preparation and the reference preparation flupentixol-melitracen tablets in healthy subjects.

Methods: In healthy adult subjects in China, LJ01003 capsules produced by Changchun Lanjiang Pharmaceutical Technology Co., Ltd. were used as the test preparation, and omeprazole magnesium enteric-coated tablets (Losec MUPS) produced by AstraZeneca Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetics and pharmacodynamics bioequivalence of the two preparations, the effect of food on the pharmacokinetic parameters of the test preparation, the comparison of pharmacokinetic parameters of the test preparation and the reference preparation at different doses, as well as the safety and tolerability were evaluated.

A bioequivalence study was conducted in accordance with the relevant bioequivalence test regulations, using dapoxetine hydrochloride tablets (30 mg) produced by Plant Biotechnology Co., Ltd. as the test preparation (T), and dapoxetine hydrochloride tablets (30 mg, Priligy®) produced by Menarini-Von Heyden GmbH as the reference preparation (R).