Guangdong Jiu Ming Pharmaceutical Co., Ltd.

The pediatric faropenem sodium granules (specification: 0.05 g) provided by Guangdong Jiuming Pharmaceutical Co., Ltd. were used as the test preparation, and the pediatric faropenem sodium granules (trade name: Feroum®, specification: 0.05 g) from the licensed manufacturer Maruho Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations were investigated in the fasting and postprandial states, and the bioequivalence of the two preparations was evaluated. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Main research purpose: According to the relevant provisions of bioequivalence test, epalrestat tablets (trade name: KINEDAK; specification: 50mg) of which Alfred Pharmaceuticals Co., Ltd. is the licensee was selected as the reference preparation, and the human bioequivalence test of fasting administration of the test preparation epalrestat tablets (specification: 50mg) produced and provided by Guangdong Jiuming Pharmaceutical Co., Ltd. was conducted to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation epalrestat tablets (specification: 50mg) and the reference preparation epalrestat tablets (trade name: KINEDAK; specification: 50mg) by healthy subjects.

Tadalafil tablets (specification: 20 mg) developed by Guangdong Jiuming Pharmaceutical Co., Ltd. were used as the test preparation, and tadalafil tablets (trade name: Cialis®, specification: 20 mg) produced by Lilly del Caribe, Inc. Puerto Rico (Puerto Rico) were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.