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

Inclusion criteria

• Subjects must be male or female adults in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
• Vital signs (after 3 minutes resting in a upright position) which are within the following ranges:

Ear body temperature between 35.0-37.5°C. Systolic blood pressure, 90-140 mm Hg. Diastolic blood pressure, 50-90 mm Hg. Pulse rate, 50-90 bpm. Fasting blood glucose, < 110 mg/dL.

• Within -20% to +20% of the ideal body weight. For male subjects, body weight must be above 50 kg and for female subjects, body weight must be above 45 kg.
• Able to sign informed consent prior to study.
• Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

• 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).
• Alcohol or caffeine ingested within 48 hours prior to dosing.
• Significant illness within 2 weeks prior to dosing.
• Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
• 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.
• Presence of cardiovascular disease.
• Presence of gastrointestinal disease.
• Presence of asthma or lung disease.
• 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).
• 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)
• Presence of neurological disease.
• Presence of psychiatric disease.
• Subject is positive for HIV immunology test.
• A known hypersensitivity to nalbuphine or its analogs.
• History of drug or alcohol abuse within 12 months prior to dosing.
• Permanent confinement to an institution.
• Pregnant or lactating women.
• Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons