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The purpose of this study is to characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant dosing schedules.
This study is an open label, randomized, two-treatment, two-period, two-sequence, single-center, crossover study comparing the pharmacokinetics, safety and tolerability of MNS075 (intranasal morphine) at doses of 7.5 mg self-administered q1h for 7 hours (8 doses) and 15 mg self-administered q3h for 9 hours (4 doses).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | MNS075 7.5mg q1h |
|
| B | Experimental | MNS075 15mg q3h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MNS075 | Drug | MNS075 7.5mg q1h MNS075 15mg q3h |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075. | Multiple |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javelin Pharmaceuticals | Javelin Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEDRA Corporation | Austin | Texas | 78754 | United States |
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