Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd

To study the pharmacokinetic characteristics of the test preparation trazodone hydrochloride tablets (specification: 50 mg, developed by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd.) and the reference preparation trazodone hydrochloride tablets (RESLIN®, specification: 50 mg, produced by Olganon Co., Ltd.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives: To study the safety of the test preparation trazodone hydrochloride tablets (specification: 50 mg) and the reference preparation trazodone hydrochloride tablets (RESLIN®, specification: 50 mg) in healthy subjects.

The main research purpose: According to the regulations on bioequivalence testing, Pioglitazone Metformin Tablets (trade name: Pioglitazone Tablets; Specification: 15mg/500mg) of Takeda Tubo Co., Ltd. as the licensee was selected as the reference preparation. Zhejiang Jinbikang Pharmaceutical The test preparation pioglitazone and metformin tablets (specification: 15mg/500mg) provided by Science and Technology Co., Ltd. were subjected to fasting and postprandial administration human bioequivalence tests to compare the absorption speed and extent of the drug in the test preparation with the reference preparation. To evaluate whether the bioequivalence of the two formulations is within the acceptable range under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of the test preparation pioglitazone metformin tablets (specification: 15mg/500mg) and the reference preparation pioglitazone metformin tablets (trade name: メタクト compound tablets; specification: 15mg/500mg) orally administered to healthy volunteer subjects.

A single-center, randomized, open, two-period, self-crossover, single-dose administration design was used to evaluate the oral bioequivalence of pioglitazone metformin tablets (15 mg/500 mg) certified by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd. and pioglitazone metformin tablets (15 mg/500 mg) certified by Takeda Teba Pharmaceutical Co., Ltd. in healthy people on an empty stomach or after a meal, to provide evidence for the consistency of clinical efficacy of pioglitazone metformin tablets certified by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd. and pioglitazone metformin tablets certified by Takeda Teba Pharmaceutical Co., Ltd., and to evaluate the safety of pioglitazone metformin tablets (15 mg/500 mg) certified by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd.