Trial · NCT05363501
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics of Various Naloxone Administrations (Maximum plasma concentration (Cmax))-Phase 1 | 17 days | To determine the pharmacokinetics (PK) of various naloxone intranasal swab doses (4, 8, and 12 mg) compared to intramuscular (IM) naloxone injection (0.4 mg dose) and naloxone nasal spray (4 mg dose) in healthy subjects. Maximum plasma concentration (Cmax) will be measured. |
| Primary | Pharmacokinetics of Various Naloxone Administrations (Area Under the Curve (AUC))-Phase 1 | 17 days | To determine the pharmacokinetics (PK) of various naloxone intranasal swab doses (4, 8, and 12 mg) compared to intramuscular (IM) naloxone injection (0.4 mg dose) and naloxone nasal spray (4 mg dose) in healthy subjects. Area Under the Curve (AUC)will be measured. |
| Primary | Pharmacokinetics of Various Naloxone Administrations (Partial Area Under the Curve (AUC))-Phase 1 | 17 days | To determine the pharmacokinetics (PK) of various naloxone intranasal swab doses (4, 8, and 12 mg) compared to intramuscular (IM) naloxone injection (0.4 mg dose) and naloxone nasal spray (4 mg dose) in healthy subjects. Partial Area Under the Curve (AUC) will be measured. |
| Primary | Dose Selection (Maximum plasma concentration (Cmax))-Phase 1 | 17 days | To identify an appropriate target intranasal swab dose using comparative PK parameters with IM naloxone injection (0.4 mg) and naloxone nasal spray (4 mg dose) in healthy subjects. Maximum plasma concentration (Cmax) will be measured. |
| Primary | Dose Selection (Area Under the Curve (AUC))-Phase 1 | 17 days | To identify an appropriate target intranasal swab dose using comparative PK parameters with IM naloxone injection (0.4 mg) and naloxone nasal spray (4 mg dose) in healthy subjects. Area Under the Curve (AUC) will be measured. |
| Primary | Dose Selection (Partial Area Under the Curve (AUC))-Phase 1 | 17 days | To identify an appropriate target intranasal swab dose using comparative PK parameters with IM naloxone injection (0.4 mg) and naloxone nasal spray (4 mg dose) in healthy subjects. Partial Area Under the Curve (AUC) will be measured. |
| Primary | Bioavailability (Maximum plasma concentration (Cmax))-Phase 2 | 13 days | To evaluate and compare the bioavailability of the identified nasal naloxone swab target dose from the Phase 1 (12.5 mg) and IM naloxone injection (0.4 mg). Maximum plasma concentration (Cmax) will be measured. |
| Primary | Bioavailability (Area Under the Curve (AUC))-Phase 2 | 13 days | To evaluate and compare the bioavailability of the identified nasal naloxone swab target dose from the Phase 1 (12.5 mg) and IM naloxone injection (0.4 mg). Area Under the Curve (AUC) will be measured. |
| Primary | Bioavailability (Partial Area Under the Curve (AUC))-Phase 2 | 13 days | To evaluate and compare the bioavailability of the identified nasal naloxone swab target dose from the Phase 1 (12.5 mg) and IM naloxone injection (0.4 mg). Partial Area Under the Curve (AUC) will be measured. |
| Secondary | Absorption Levels-Phase 1 and 2 | 17 days | To compare the absorption levels of intranasal naloxone swab at early time points post -delivery (within the first 15 minutes) with IM naloxone injection (0.4 mg) and naloxone nasal spray (4 mg dose) in healthy subjects. |
| Secondary | Safety of Naloxone Swab- (Treatment emergent adverse events (TEAEs))-Phase 1 and 2 | 17 days | To determine the safety and tolerability of intranasal naloxone swab doses (4, 8, 12 and 12.5 mg), particularly with respect to nasal irritation (erythema, edema, and erosion) and olfactory nerve abnormalities in healthy subjects. will be included in the adverse event summaries. |
| Secondary | Absorption Levels-Phase 2 | 13 days | To compare the absorption levels of the nasal swab at early time points post-delivery (within the first 15 minutes) with IM naloxone injection (0.4 mg) and naloxone nasal spray (4 mg dose) in healthy subjects. |
| Secondary | Dose Proportionality-Phase 2 | 13 days | To evaluate the dose proportionality of naloxone nasal swab target dose (12.5 mg). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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