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This study is to evaluate the relative bioavailability of nalbuphine after single IM injection of Sebacoyl Dinalbuphine Ester (SDE) injection and Bain®, Nalbuphine HCl IM injection in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period I (reference drug) | Experimental | Before administration of investigational products, subjects should be fasted for 10 hours. On the dosing day, subjects will be confined after administration and won't be discharged until after completion of sample collections for 24 hours following dosing in Period I (Bain® IM injection). |
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| Period II (Test drug) | Experimental | Subjects will be back to the clinical site to join Period II (SDE IM injection) and will be discharged after completion for sample collections for 24 hours post drug administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bain® | Drug | Nalbuphine HCl 20mg, IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of Nalbuphine HCl | Protocol-specified pharmacokinetic parameters will be determined from blood samples collected after each administration of study drug to assess the relative bioavailability of SDE. | Period I: pre-dose (0 h) and 0.083, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose for Bain®, Nalbuphine HCl IM injection ; Period II: pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post dose for SDE IM injection |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University - Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| C420448 | sebacoyl dinalbuphine ester |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| SDE | Drug | Sebacoyl Dinalbuphine Ester 150mg/2ml, IM injection |
|
|
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |