Severe chronic pain
Conditions
Interventions
Fasting TR/RT group:In the first cycle, all participants were fasted for at least 10 hours, and a blank blood sample was collected on the morning of each cycle of dosing, and 1 tablet of the test prep
Postprandial TR/RT group:In the first cycle, all participants were fasted for at least 10 hours, and a blank blood sample was collected on the morning of each cycle of dosing, and 1 tablet of the test
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~55 years old (including boundary value), both male and female; 2. Female participants weigh >=45.0kg, male participants weigh >=50.0kg, and body mass index (BMI) is between 19.0~26.0kg/m2 (including boundary value) (BMI=weight kg/height m^2); 3. Those with a history of chronic pain (regardless of the cause) (including but not limited to knee joint, shoulder joint and other bone and joint pain, frozen shoulder pain, cervical spine, lumbar intervertebral disc herniation, etc.); 4. When not receiving analgesics, the average pain score over the past 24 hours should be <=4 as assessed by the Numeric Pain Scale (NRS). Pain condition that has been stable for at least 7 days prior to the screening period and is predicted to remain stable throughout the study period; 5. Participants and their female partners are willing to have no fertility plan and voluntarily take effective contraceptive measures and no sperm and egg donation plans from 2 weeks before screening to 6 months after the last dose of study drug, and guarantee the use of one or more non-drug contraceptive measures in sexual life from 2 weeks before screening to 1 month after the last dose of study drug; 6. Participants should sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial; Voluntary participation and ability to complete the study as required by the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Diseases that need to be excluded due to abnormal clinical manifestations that occur or are occurring before screening, including but not limited to neurological/psychiatric system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any history of gastrointestinal diseases that affect drug absorption), blood and lymphatic system, urinary system, endocrine system, and immune system; 2. Those with a history of digestive tract diseases, especially any gastrointestinal diseases that affect drug absorption (such as gastric or small bowel resection, gastric or duodenal ulcer, atrophic gastritis, gastrointestinal bleeding, obstruction, cholecystitis, gallstones, etc.); 3. Those with respiratory depression or high risk of respiratory depression (such as sleep apnea syndrome, bronchial asthma), history of epilepsy, history of hypotension, psychiatric diseases (such as depression) or long-term use of psychotropic drugs; 4. Those who have other serious diseases in the past 4 weeks except for the primary chronic pain disease; 5. Those who cannot tolerate venipuncture or have a history of needle sickness or blood sickness; 6. Modified Mahalanobis score > grade II or dysphagia; 7. Those who have undergone surgery within 3 months before screening or plan to undergo surgery during the study period, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs; 8. Those who have used or are using any drug metabolism that significantly affects the level of drug metabolism in this test within 1 month before screening (such as monoamine oxidase (MAO) inhibitors, serotonin, norepinephrine reuptake inhibitors (SNRIs), muscle relaxants, diuretics and anticholinergics, etc.); 9. Those who have used drugs that significantly inhibit or induce glucuronosyltransferase (UGT) UGT1A6, UGT1A9 and UGT2B7 isoenzymes within 1 month before screening (including prescription drugs, over-the-counter drugs, health care products or Chinese herbal products, etc., such as diclofenac, diflunisal, indomethacin, niflufenamic acid, efavirenz, spironolactone, baicalin, astragalus extract, phenobarbital, rifampicin); 10. Those who have taken any prescription drugs, any over-the-counter drugs, Chinese herbal medicines or health care products within 14 days before screening; 11. Those who have used opioids or opioids within 7 days before screening; 12. Those who are positive for drug abuse screening (morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, cocaine) or have a history of drug abuse in the past five years or have used soft drugs (such as marijuana) in 3 months before the test or have taken hard drugs (such as phencycline hexidine) in 1 year before the trial; 13. Those who are allergic to any of the ingredients in this product and its excipients (especially those who have had bronchospasm or angioedema), or those who are allergic to similar drugs (such as oxycodone, dihydromorphone, morphine, fentanyl), or those who have a specific history of allergy (such as allergic asthma, urticaria, eczema, etc.) or allergies (such as allergies to two or more drugs, food or pollen; or prone to allergic reactions and no cause can be found); 14. Those who have received vaccination within 1 month before screening or are vaccinated during the planned trial; 15. Blood donation within 3 months before screening, including those who have component blood or large blood l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t;Tmax;t1/2z;AUC_%Extrap;?z; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;SAE; | — |
Countries
China
Contacts
Public ContactXie Zhihong/Wang Bin
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed