pain
Conditions
Interventions
Group A:0.1 mg test preparation
Group B:0.1 mg reference preparation
Group C:0.2 mg test preparation
Group D:0.2 mg reference preparation
Sponsors
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be selected: 1. Aged 18-55 years (including boundary value), male or female; 2. The weight of male subjects >= 50.0 kg, the weight of female subjects >= 45.0 kg, and the body mass index (BMI) is between 19~26 kg/?, including critical values; 3. Average pain scores over the past 24 hours assessed using the Digital Pain Scale (NRS) should be < 4 when a history of chronic pain is not receiving analgesics, and pain disorders remain stable in the near term and are predicted to remain stable throughout the study period; 4. Agree that no unprotected sexual activity will occur from the date of screening to 3 months after the test, and non-drug contraceptive measures must be used during the trial (pharmacological contraception includes oral contraceptives, contraceptive injections, subcutaneous embedded contraceptives, local contraceptives such as spermicides, etc.) and the results of female blood pregnancy (ß-HCG) examination are not clinically significant; 5. The subject voluntarily signs a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1. Those who have suffered or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolism or any other diseases that can interfere with the test results; 2. Have a history of dysphagia or gastrointestinal diseases (such as gastric or small bowel resection, atrophic gastritis, gastrointestinal ulcer and/or gastrointestinal bleeding, obstruction, etc., except appendicitis appendectomy), or suffer from paralytic intestinal obstruction, gastrointestinal stricture, acute abdomen, and now feel digestive tract discomfort; 3. Patients with biliary tract disease, cholecystitis, pancreatitis, prostatic hypertrophy, thyroid dysfunction, adrenal insufficiency or urethral stricture; 4. Those with a history of seizures or increased intracranial pressure, brain swelling and pain, head injury or impaired consciousness; 5. Have a history of frequent or extensive bilateral oral ulcers, oral herpes or Sjogren's syndrome, or currently need oral pathological examination, or have dentures or braces that interfere with tablet placement; 6. Frequent heart or vomiting history caused by any cause; 7. Have a history of allergies to drugs (including fentanyl citrate and naltrexone), food or other substances; 8. Those who have undergone surgery within 4 weeks prior to the trial, or who plan to undergo surgery during the study; 9. Those who receive active or attenuated vaccines within 1 month before the test or during the planned trial; 10. Those who have taken any drug or health supplement (including Chinese herbal medicine) within 14 days prior to the use of the study drug; 11. Those who have used any drug that induces liver metabolism of the drug (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) within 30 days before the use of the study drug; 12. Those who have participated in any clinical trial and taken any clinical trial drug within 3 months before the trial; 13. Those who donated blood or lost a large amount of blood (>= 200 mL, except for women's menstrual blood loss), received blood transfusions or used blood products within 3 months before selection; 14. Pregnant or lactating women; 15. Those who have special requirements for diet and cannot comply with the uniform diet; 16. Those who have difficulty in venous blood collection or have needle sickness or blood sickness; 17. Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day; 18. There is no guarantee that from 48 hours before the use of the study drug to the end of the study, any beverage or food rich in xanthine (such as animal liver), caffeine, theophylline (such as chocolate, tea, coffee and cola, etc.), or grapefruit fruit (grapefruit) or products containing grapefruit ingredients are prohibited; 19. Those who smoked more than 5 cigarettes per day in the 3 months before the test or could not stop using any tobacco products during the trial; 20. Positive alcohol breath test result or regular drinker in the 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits or 150 mL of wine with 40% alcohol content) or who cannot stop using any alcoholic products during the test; 21. Those
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SpO2;Plasma Concentration;Blood pressure;body temperature; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Wen Ouyang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed