A Bioavailability Study of Sebacoyl Dinalbuphine Ester IM Injection in Healthy Volunteers

Exclusion Criteria

• •1. Use of any alcohol-containing products, prescription medications or over-the-counter, non-prescription preparations (including herbal preparations) within 2 weeks prior to study entry unless deemed acceptable by the Investigator (except up to 5 doses of ≤ 1000 mg of acetaminophen or ≤ 400 mg ibuprofen within this 2 week period).
• •2. Alcohol or caffeine ingested within 48 hours prior to dosing.
• •3. Significant illness within 2 weeks prior to dosing.
• •4. Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
• •5. Donation or loss of more than 500 mL of blood within 3 months prior to dosing. Donation or loss of more than 250 mL of blood within 2 months prior to dosing.
• •6. Presence of cardiovascular disease.
• •7. Presence of gastrointestinal disease.
• •8. Presence of asthma or lung disease.
• •9. Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as AST, ALT, gamma-GT, Alkaline Phosphatase, or Total Bilirubin. (value of AST or ALT above 3 times of the upper limit of the normal range; other items clinically significant abnormality judged by investigator).
• •10. Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents. (value of creatinine or BUN beyond the range from -20% of the lower limit of the normal range to +20% of the upper limit of the normal range; other items clinically significant abnormality judged by investigator)
• •11. Presence of neurological disease.
• •12. Presence of psychiatric disease.
• •13. Subject is positive for HIV immunology test.
• •14. A known hypersensitivity to nalbuphine or its analogs.
• •15. History of drug or alcohol abuse within 12 months prior to dosing.
• •16. Permanent confinement to an institution.
• •17. Pregnant or lactating women.
• •18. Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons