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This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.
To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | oral ketamine |
|
| B | Experimental | intranasal ketamine |
|
| C | Active Comparator | intravenous ketamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal ketamine | Drug | A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study. |
| Measure | Description | Time Frame |
|---|---|---|
| ketamine pharmacokinetics | 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 |
|---|---|---|---|---|---|---|
| Javelin Pharmaceuticals | Cambridge | Massachusetts | 02140 | United States |
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