RecruitingPhase 1Phase 2NCT06780267
Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics
Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Enrollment
195 participants
Start Date
Mar 11, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Able and willing to provide a written informed consent
- Subjects requiring elective orthopedic surgery
- Conform to the ASA Physical Status Classification
Exclusion Criteria9
- Subjects with a history of severe allergies
- Subjects with nervous system disease
- Subjects with a history of mental illness
- Subjects with abnormal liver and renal function
- Subjects with poorly controlled hypertensive or hypotensive
- QTc：\>450ms（male），\>470ms（female）
- Subjects who screened positive for substance abuse
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
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Interventions
DRUGHRS-2129
HRS-2129
DRUGHRS-2129 placebo
HRS-2129 placebo
DRUGTramadol Hydrochloride SR Tablets
Tramadol Hydrochloride SR Tablets
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06780267