A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

Exclusion Criteria

• •Patients with allergy to opioids or any component of the trial drug；
• •Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;
• •Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety；
• •Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;
• •Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;
• •Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;
• •A history of drug, drug, and/or alcohol abuse；
• •Participate in any clinical trail within 30 days;
• •Pregnant or lactating female subjects；
• •Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.；
• •Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.