pain
Conditions
Interventions
A:Dosing regimen 1: Starting from the 0th h on day 1, each oral administration of 2 tablets of oxycodone hydrochloride sustained-release tablets 5mg/325mg (oxycodone hydrochloride/acetaminophen), admi
B:Dosing regimen 2: starting from the 0th hour on day 1, take 1 tablet of aminophenol oxycodone tablets 5mg/325mg (oxycodone hydrochloride/acetaminophen) orally each time, administered every 6 hours,
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following criteria to be selected: 1) Volunteers fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer as volunteers, and sign informed consent before the start of any research procedure; 2) Volunteers can communicate well with researchers, and understand and comply with the requirements of this study; 3) volunteers (including male volunteers) who had taken effective contraception within 14 days prior to randomization and were willing to take effective contraception voluntarily during the trial period and within 6 months after the last dose; 4) Male and female volunteers aged 18~50 with a history of non-cancerous chronic pain (regardless of etiology) (including the cut-off value); 5) Numerical Rating Scale (NRS) score =4 in the first 24 hours of randomization; 6) stable pain symptoms within 14 days before randomization, and pain symptoms could remain relatively stable throughout the study period predicted according to medical history; 7) Male volunteers weigh no less than 50 kg. Female volunteers weighed at least 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 19.0~26.0 (including critical value);
Exclusion criteria
Exclusion criteria: Volunteers who meet one or more of the following criteria will be excluded: 1)Previous or current circulatory, endocrine, nervous system (vertigo syndrome, stroke sequelae, including but not limited to abnormal respiratory rhythm, hemiplegia, aphasia, limb paresthesia; Other central nervous system diseases such as intracranial tumors, craniocerebral injury, intracranial hypertension from any cause and other intracranial diseases that may affect the respiratory center), digestive system (nausea, vomiting, gastrointestinal obstruction, paralytic intestinal obstruction, etc.), respiratory system (insufficiency of ventilation, SpO2=95%, bronchial asthma, chronic obstructive pulmonary disease, obstructive sleep apnea-hypopnea syndrome), genitourinary system,Hematology, immunology, psychiatry, metabolic abnormalities and other serious clinical diseases or any other diseases that can interfere with the test results (except the primary non cancerous Chronic pain); 2) Have a history of allergies to drugs, food, or other substances; 3) Those who have undergone surgery within the first 4 weeks of randomization or plan to undergo surgery during the study period; 4) Individuals who have taken any medication or health products (including Chinese herbal medicine) within the first 7 days of randomization; 5) Those who have participated in any clinical trial and taken any clinical trial medication within the first 3 months of randomization; 6) Individuals who donate blood or experience significant blood loss (= 200 mL, excluding female menstrual blood loss), receive blood transfusions, or use blood products within the first 3 months of randomization; 7) Pregnant or lactating women, as well as volunteers who are unable to use one or more non pharmacological contraceptive methods during the trial period; 8) Those who have special dietary requirements and cannot follow a unified diet; 9) Drinking excessive amounts of tea, coffee, and/or caffeinated beverages (8 or more cups, 1 cup=250 mL) every day; 10) Smokers or those who smoke more than 5 cigarettes per day in the first 3 months of randomization, or those who cannot stop using any tobacco products during the trial period; 11) Alcoholics (including alcohol abuse or addiction) or those who regularly drink alcohol within the first 6 months of randomization, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or cannot stop using any alcoholic products during the trial period; 12) Drug abusers (including drug abuse or addiction) or those who have used soft drugs (such as marijuana) in the first three months of randomization or taken hard drugs (such as cocaine, phencyclidine, etc.) in the first year of randomization; 13) Individuals with abnormal vital signs (systolic blood pressure140 mmHg, diastolic blood pressure90 mmHg; pulse100 bpm; breathing20 times/min; SpO2 = 95%;) or those with abnormal physical examination, electrocardiogram, or laboratory examination have clinical significance (based on the judgment of the clinical research doctor); 14) People with postural Hypotension, history of needle or blood sickness or intolerance of Venipuncture blood collection; 15) Those who have received vaccines within the first month of randomization or plan to receive vaccines during the trial period; 16)Volunteers may not be able to complete this study due to other reasons or those who the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;Tmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;laboratory test; | — |
Countries
China
Contacts
Public ContactGuoping YANG
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed