Chronic pain
Conditions
Interventions
Trial-Reference Group:First cycle test preparation (T, LY021702)
second cycle reference preparation (R, Targin)
Refence-Trial Group:First cycle reference preparation (R, Targin)
second cycle test preparation (T, LY021702)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. The informed consent of this trial must be signed before the trial, and a written informed consent form must be signed voluntarily, which can maintain good communication with the investigator and comply with the various requirements of the clinical trial (planned visits, laboratory inspections and other research procedures) By; 2. Males or females with chronic pain (non-cancer pain) aged 18 to 55 years (including boundary value); 3. When not receiving analgesics, use the Digital Pain Scale (NRS) to evaluate the average pain score in the past 24 hours should be less than 4. Pain conditions remain stable for at least 7 days before screening and are predicted to remain stable throughout the study period; 4. When screening, the weight of the male is >=50.0kg, the weight of the female is >=45.0kg, and the body mass index (BMI) is between 19.0 and 28.0kg / m2 (including boundary values; BMI = weight / height 2); 5. Except for pain-related symptoms and signs during screening (including vital signs, physical examination, blood routine, urine routine, blood biochemistry, 12-lead ECG, chest radiograph, etc.), the results were normal or abnormal, but the researchers The judgment has no clinical significance or the investigator's judgment has clinical significance (except for liver and kidney function and ECG have clinical significance), but does not affect this clinical trial; 6. Patients (including male subjects) are willing to have no fertility plan and voluntary effective contraception and no sperm donation and egg donation plans from 2 weeks before screening to the entire study period, and guarantee sexual life from 2 weeks before screening to the entire study period One or more non-drug contraceptives are used.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Those who are allergic to any component of the test drug or similar drugs, and those who are allergic; 3. Have any disease (such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system disease) or medical history that may prevent the subject from following the test protocol and completing the test; 4. Patients with a history or symptoms of orthostatic hypotension; or a systolic blood pressure (SBP) decrease of >=20mmHg or a diastolic blood pressure (DBP) decrease of >=10mmHg within 3 minutes from the lying position to the upright position at the screening visit; 5. Hepatitis B surface antigen (HbsAg), anti-hepatitis C virus antibody (HCV-Ab), anti-human immunodeficiency virus antibody (Anti-HIV), and syphilis antibody were positive at screening; 6. History of dizziness or needle halo or inability to tolerate venipuncture; 7. Any drug (including vitamins, Chinese herbs and / or calcium) is used within 14 days before the first dose or is expected to be used throughout the study period, except for the stable application of acetaminophen or ibuprofen for at least 14 days before the study Dosage and frequency of treatment remain unchanged during the period); 8. Participants in other clinical trials within 3 months before screening; 9. Those who have been vaccinated within 1 month before screening; 10. Blood donation within 3 months before screening, including component blood or massive blood loss (>=200mL), those receiving blood transfusions or using blood products; 11. People with a history of drugs or substance abuse, alcohol or smokers: (1) People with a history of drug abuse or drug abuse, or a positive urine screening result at screening; (2) Drinks containing 14 units of alcohol per week (1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine) on average every week for the 3 months before screening, or a positive alcohol test (screening value greater than "0 ")By; (3) The average daily smoking volume in the 3 months before screening >=5; 12. Intake foods or beverages rich in xanthine (such as tea, coffee, cola or chocolate) within 3 days before administration; 13. Ingestion of foods or beverages containing grapefruit and / or grapefruit within 7 days before administration; 14. Those who cannot comply with the dietary requirements of the program; 15. Any other reason the researcher considers unsuitable for enrollment or unable to complete the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;F; | — |
Countries
China
Contacts
Public ContactZhu Luo
West China Hospital,Si Chuan University
Outcome results
None listed