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| Name | Class |
|---|---|
| Purdue Pharma LP | INDUSTRY |
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This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Nalmefene + 0.94% MgCl2 (IV) |
|
| Treatment B | Experimental | Nalmefene + 0.94% MgCl2 (IM) |
|
| Treatment C | Active Comparator | Nalmefene Hydrochloride injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalmefene + 0.94% MgCl2 | Drug | Nalmefene 0.5 mg + 0.94% MgCl2 for IV (bolus) administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC0-2.5) | Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | 2.5 minutes post-dose |
| Area Under the Curve (AUC0-5) | Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | 5 minutes post-dose |
| Area Under the Curve (AUC0-10) | Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | 10 minutes post-dose |
| Area Under the Curve (AUC0-15) | Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | 15 minutes post-dose |
| Area Under the Curve (AUC0-20) | Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | 20 minutes post-dose |
| Area Under the Curve (AUC0-30) | Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration |
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Key Inclusion criteria:
Key Exclusion criteria:
Other inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio Clinical Trials | Columbus | Ohio | 43212 | United States |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
| D015636 | Magnesium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Nalmefene + 0.94% MgCl2 |
| Drug |
Nalmefene 0.5 mg + 0.94% MgCl2 for IM administration |
|
| Nalmefene Hydrochloride Injection | Drug | Nalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration |
|
| 30 minutes post-dose |
| Area Under the Curve (AUCt) | Area under the plasma concentration-time curve from time zero to the time of last measurable concentration following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | Up to 48 hours post-dose |
| Area Under the Curve (AUCinf) | Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | Up to 48 hours post-dose |
| Maximum Plasma Concentration (Cmax) | Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration | Up to 48 hours post-dose |
| Area Under the Curve (AUC0-2.5) | Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | 2.5 minutes post-dose |
| Area Under the Curve (AUC0-5) | Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | 5 minutes post-dose |
| Area Under the Curve (AUC0-10) | Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | 10 minutes post-dose |
| Area Under the Curve (AUC0-15) | Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | 15 minutes post-dose |
| Area Under the Curve (AUC0-20) | Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | 20 minutes post-dose |
| Area Under the Curve (AUC0-30) | Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | 30 minutes post-dose |
| Area Under the Curve (AUCt) | Area under the plasma concentration-time curve from time zero to the time of last measurable concentration following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | Up to 48 hours post-dose |
| Area Under the Curve (AUCinf) | Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | Up to 48 hours post-dose |
| Maximum Plasma Concentration (Cmax) | Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration | Up to 48 hours post-dose |
| D064419 |
| Chemically-Induced Disorders |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |
| D017616 |
| Magnesium Compounds |