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Objective:To evaluate the pharmacokinetic characteristics and safety of single and multiple intravenous injections of nalbuphine hydrochloride injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nabufine Hydrochloride Injection | Drug | PartA: Nabufine Hydrochloride Injection are administered Intravenous injection single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum drug plasma concentration) | up to 12 hours after first administration | |
| AUC0-t (Total area under the plasma drug concentration-time curve from time of administration to the time of the last quantifiable drug concentration) | up to 12 hours after first administration | |
| AUC0-∞ (Total area under the plasma drug concentration-time curve) | up to 12 hours after first administration | |
| Tmax (Time to achieve Cmax) | up to 12 hours after first administration | |
| T1/2z (Apparent terminal elimination half-life) | up to 12 hours after first administration | |
| AUC_%Extrap (The percentage of the portion estimated through extrapolation) | up to 12 hours after first administration | |
| MRT (Mean residence time) | up to 12 hours after first administration | |
| CLz (Clearance of the analyte in plasma) | up to 12 hours after first administration | |
| Occurence of adverse events | up to 5 days for part A, up to 7 days for part B |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | China |
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| Nabufine Hydrochloride Injection | Drug | PartB: Nabufine Hydrochloride Injection are administered Intravenous injection multi dose |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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