Impacted Tooth Extraction
Conditions
Interventions
100mg:HR18042 100mg
125mg:HR18042 125mg
200mg:HR18042 200mg
Positive-Drug:Tramadol Hydrochloride Sustained Release Tablets 100mg
Placebo:Placebo
Sponsors
West China School of Stomatology Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) 18 to 75 years on the day of signing the informed consent form,no gender limit; 2) At least one impacted mandibular third molar must be removed and the bone removed at the same time during the operation; 3) Any time VAS >= 5 within 4 hours after extraction of impacted tooth; 4) Weight of 45 to 100 kg; 5) Females of childbearing age have a negative pregnancy test within 7 days before randomization and are willing to take reliable contraceptive measures (such as intrauterine devices, contraceptives, condoms, etc.) during the study; male subjects whose partners are females of childbearing age are willing take effective contraceptive measures or have undergone sterilization during the study period; 6) Able to correctly understand research procedures and methods and comply with research regulations; 7) Signed informed consent and voluntarily joined the study.
Exclusion criteria
Exclusion criteria: 1) Used any anesthetic or analgesic drug other than the short-acting local anesthetic prescribed in the protocol within 12 hours before randomization; 2) Used any NSAIDs within 4 days before randomization, or used short-acting non-steroidal anti-inflammatory drugs within 1 day before randomization; 3) Taken monoamine oxidase inhibitors, tricyclic antidepressants, SSRIs (such as paroxetine, dooxetine, fluoxetine, etc.), SNRIs (such as minocillin, duloxetine, venlafaxine, etc.) within 30 days before randomization, Weight loss drugs (including fenfluramine, phentermine, etc.), methylphenidate hydrochloride (ritalin), opioid agonists/antagonists, other antipsychotics, etc.; 4) Complications such as infection at the site of oral surgery; 5) Severe cardiovascular and cerebrovascular diseases, such as myocardial infarction, hemorrhagic or ischemic stroke within 3 months before screening; 6) Gastrointestinal ulcers, gastrointestinal bleeding or other serious gastrointestinal diseases with endoscopic records within 6 months before screening; 7) History of epilepsy, drug abuse or alcohol abuse in the 6 months before screening (alcoholism refers to the average daily drinking of more than 720ml of beer or 90mL of 40% alcohol or 300mL of wine); 8) Sitting systolic blood pressure >= 160mmHg or = 100mmHg or = 450ms, female >= 470ms) or there are other obvious clinically significant ECG abnormalities (such as type II, type III atrioventricular block, sick sinus syndrome, etc.) during the screening period; 10) Obvious laboratory abnormalities during the screening period: a. Hemoglobin (Hb) = 2.5 x ULN (upper limit of normal); c. Serum aspartate aminotransferase (AST) >= 2.5 x ULN; d. Serum total bilirubin (TBIL) >= 1.5 x ULN; e. Serum creatinine (Cr) >= 1.5 x ULN; f. Fasting blood glucose (FPG) >= 11.1mmol/L; g. PT>ULN+3s and/or APTT>ULN+10s; h. Human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), syphilis antibody positive; 11) Known allergy or intolerance to tramadol, opioids, NSAIDs, or short-acting surgical anesthetics prescribed by the protocol; 12) Women who are pregnant or breastfeeding or have a family plan in the past 3 months (including men); 13) Participated in other clinical studies and used research drugs containing active ingredients within 30 days before screening; 14) The investigator judged other reasons that are inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPID; | — |
Countries
China
Contacts
Public ContactBing Shi
West China School of Stomatology Sichuan University
Outcome results
None listed