About this trial
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial. To preliminarily evaluate the safety and efficacy of KHN702 tablets in moderate to severe post-operative pain patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects between the ages of 18 and 75 years, inclusive.
Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
Patients scheduled for surgery.
According to the researcher's medical judgment, American Society of Anesthesiologists (ASA) classification≤Grade II.
Disqualifiers
Participants experiencing acute or chronic pain unrelated to the surgical site, which the investigator deems may confound the participant's assessment of postoperative pain.
History of significant cardiovascular or cerebrovascular disease;
Severe respiratory disease history;
Severe Neurological and Psychiatric disease History;
Trial design
Parallel
Treatments tested in this trial
KHN702
DrugKHN702 tablet for oral administration
KHN702 placebo
DrugKHN702 placebo tablet for oral administration
Treatment groups
Trial outcomes
Primary outcomes
Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose
Secondary outcomes
Safety:Incidence and severity of Adverse Events( AE)/SAE
Cmax
Maximum Plasma Concentration
Time-weighted the Sum of Pain Intensity Differences in Pain Score over Times
Times and Cumulative Amount of Rescue Analgesics Used by Subjects within 0 to 48 Hours after the First Dose.
Locations
Sponsors and contacts
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