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| ID | Type | Description | Link |
|---|---|---|---|
| B4541005 |
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This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Placebo Comparator | Placebo |
|
| Treatment B | Experimental | EMBEDA 30 mg crushed |
|
| Treatment C | Active Comparator | Morphine Sulfate Controlled Release 30 mg crushed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Lactose (100 mg) placebo tablets crushed; single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Liking Visual Analog Scale maximum peak effect (Emax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose | |
| Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose | |
| High Visual Analog Scale maximum peak effect (Emax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose | |
| High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose | |
| Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23936895 | Derived | Setnik B, Goli V, Levy-Cooperman N, Mills C, Shram M, Smith I. Assessing the subjective and physiological effects of intranasally administered crushed extended-release morphine formulations with and without a sequestered naltrexone core in recreational opioid users. Pain Res Manag. 2013 Jul-Aug;18(4):e55-62. doi: 10.1155/2013/952082. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| EMBEDA - morphine sulfate/ naltrexone hydrochloride |
| Drug |
EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose |
|
| morphine sulfate CR crushed. | Drug | Morphine sulfate controlled release 30 mg tablet crushed |
|
| Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Drug Liking Visual Analog Scale Area time to maximum effect (TEmax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| High Visual Analog Scale Area time to maximum effect (TEmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale maximum peak effect (Emax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale maximum peak effect (Emax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale maximum peak effect (Emax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax) | 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale maximum peak effect (Emax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Feel Sick Visual Analog Scale Area time to maximum effect (TEmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale maximum peak effect (Emax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Nausea Visual Analog Scale Area time to maximum effect (TEmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale maximum peak effect (Emax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Sleepy Visual Analog Scale Area time to maximum effect (TEmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale maximum peak effect (Emax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Dizzy Visual Analog Scale Area time to maximum effect (TEmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter minimum peak effect (Emin) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter time to minimum peak effect (TEmin) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose |
| Take Drug Again Visual Analog Scale maximum peak effect (Emax) | 12 and 24 hours post dose |
| Take Drug Again Visual Analog Scale mean (Emean) | 12 and 24 hours post dose |
| Overall Drug Liking Visual Analog Scale maximum peak effect (Emax) | 12 and 24 hours post dose |
| Overall Drug Liking Visual Analog Scale mean (Emean) | 12 and 24 hours post dose |
| Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Burning maximum peak effect (Emax) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Nasal Congestion maximum peak effect (Emax) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h) | pre dose and 0.5, 1, 1.5, and 2 hours post dose |
| Plasma morphine - Maximum observed plasma concentration (Cmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Time to maximum observed plasma concentration (Tmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Maximum observed plasma concentration (Cmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone - Time to maximum observed plasma concentration (Tmax) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h) | pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D009293 | Opioid-Related Disorders |
| D000377 | Agnosia |
| D059350 | Chronic Pain |
| D000084783 | Recreational Drug Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
Not provided
Not provided