Shanghai Jinshan Pharmaceutical Co., Ltd.

Main study purpose: According to the relevant provisions of bioequivalence test, furosemide tablets (trade name: LASIX®, specification: 20 mg) of US PHARMACEUTICAL HOLDINGS II LLC/Validus Pharmaceuticals Llc were selected as the reference preparation, and the test preparation furosemide tablets (specification: 20 mg) produced and provided by Shanghai Ideal Pharmaceutical Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, 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 and postprandial administration conditions. Secondary study purpose: To observe the safety of oral administration of the test preparation furosemide tablets (specification: 20 mg) and the reference preparation furosemide tablets (trade name: LASIX®, specification: 20 mg) by healthy volunteers.

Dopamine tablets (specification: 0.25 g) developed by Shanghai Ideal Pharmaceutical Co., Ltd. were used as the test preparation, and dopamine tablets (trade name: Madopar®, specification: 0.25 g) certified by Shanghai Roche Pharmaceuticals Co., Ltd. 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.

The main purpose of the study is to use the nimesulide tablets (trade name: AULIN®) certified by Helsinn Birex Pharmaceuticals Ltd. as the reference preparation and the nimesulide tablets produced by Shanghai Ideal Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in humans through a single-dose, randomized, open, two-sequence, two-cycle, double-crossover, fasting and postprandial clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.