Guangzhou Yongzheng Pharmaceutical Co.,Ltd.

A single constant-rate intravenous infusion of low, medium, or high doses (12.5 mg, 25 mg, or 50 mg) of dexketoprofen tromethamine injection or multiple constant-rate intravenous infusions of dexketoprofen tromethamine injection (50 mg) was performed, and blood and urine samples were collected. The drug concentrations in plasma and urine were determined, and the PK parameters of single (multiple) doses were estimated. The PK characteristics of single (multiple) doses of dexketoprofen were analyzed, and the safety of single (multiple) doses of dexketoprofen in healthy subjects was investigated.

1) Primary objective: To demonstrate the effectiveness of dexketoprofen tromethamine in the treatment of postoperative pain by measuring the morphine consumption within 24 hours after surgery. 2) Secondary objective: To demonstrate the effectiveness of dexketoprofen tromethamine in the treatment of postoperative pain by measuring the VAS scores of patients at different time periods, the proportion of patients using rescue medication, the number of PCA compressions, and other aspects, and to demonstrate the safety of dexketoprofen tromethamine by measuring the incidence of adverse reactions.

A single constant-rate intravenous infusion of 50 mg of dexketoprofen tromethamine injection was performed, and blood and urine samples were collected for testing. The rationality of the intravenous infusion drug administration method, operation process, blood collection time point, etc. was investigated to provide a basis for formal trials; the analysis method of drug concentration in plasma and urine samples was verified.