Suzhou Thery Pharmaceutical Co., Ltd.

A single-center, randomized, open, two-period crossover, single-dose design was used to compare the differences in absorption extent and rate between dapoxetine hydrochloride tablets (specification: 30 mg) produced by Suzhou Terui Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 30 mg) certified by Berlin-Chemie AG in healthy Chinese people under fasting and fed conditions, to evaluate the bioequivalence of the two oral preparations under fasting and fed conditions, and to evaluate the safety of dapoxetine hydrochloride tablets (specification: 30 mg) produced by Suzhou Terui Pharmaceutical Co., Ltd.

Main purpose: This study used Nicergoline Tablets (specification: 10 mg) developed by Suzhou Terui Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, Nicergoline Tablets (specification: 10 mg, trade name: SERMION) produced by the original manufacturer Pfizer Italia S.r.l. was used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: Observe the safety of the test preparation Nicergoline Tablets and the reference preparation Nicergoline Tablets (trade name: SERMION) in healthy subjects.

This study used esomeprazole magnesium enteric-coated capsules (40 mg/capsule) developed by Suzhou Terui Pharmaceutical Co., Ltd. as the test preparation and esomeprazole magnesium enteric-coated capsules (40 mg/capsule, trade name: Nexium®) from the original manufacturer AstraZeneca Pharmaceuticals LP as the reference preparation to evaluate whether the test preparation and the reference preparation are bioequivalent in the postprandial/fasting/sprinkling administration state. At the same time, the safety of the test preparation and the reference preparation in healthy subjects was observed.