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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004989-18 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| University of Iceland | OTHER |
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The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naloxone intranasal | Experimental | 2.0 mg by the nasal route |
|
| naloxone intravenous | Active Comparator | 1.0 mg intravenous |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naloxone intranasal | Drug | If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally |
|
| Measure | Description | Time Frame |
|---|---|---|
| preliminary bioavailability of nasal naloxone | measured as ratio of area under the time concentration curve for nasal over intravenous naloxone x 100. Plasma concentration data will be analyzed by non-compartmental techniques. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| time to maximum concentrations | 2 weeks | |
| maximum concentration | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øyvind Ellingsen, MD PhD | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of circulation and medical imaging, NTNU | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31556537 | Result | Tylleskar I, Skulberg AK, Nilsen T, Skarra S, Dale O. Naloxone nasal spray - bioavailability and absorption pattern in a phase 1 study. Tidsskr Nor Laegeforen. 2019 Sep 23;139(13). doi: 10.4045/tidsskr.19.0162. Print 2019 Sep 24. English, Norwegian. |
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| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| naloxone intravenous | Drug | The parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position |
|
| D001523 | Mental Disorders |