Trials / Completed
CompletedNCT04713709
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder and Narcan® 4 mg/0.1 mL Nasal Spray Under Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Nasus Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.
Detailed description
A comparison between FMXIN001 4 mg and Narcan® 4 mg/0.1 mL Nasal Spray under Fasting Conditions. A pharmacokinetic study in healthy volunteers
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Nasus Pharma FMXIN001 | A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device |
| COMBINATION_PRODUCT | Nasal Naloxone liquid spray | A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device |
Timeline
- Start date
- 2021-01-31
- Primary completion
- 2021-03-30
- Completion
- 2021-10-10
- First posted
- 2021-01-19
- Last updated
- 2022-05-02
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04713709. Inclusion in this directory is not an endorsement.