Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04713709 | A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder | PHASE1 | COMPLETED | 46 | — | — | Jan 31, 2021 | Oct 10, 2021 | May 2, 2022 | 1 | Canada |
Pharmacokinetic Parameters
Pharmacokinetic Parameters
Pharmacokinetic Parameters
Pharmacokinetic Parameters
Pharmacokinetic Parameters
| Arm | Type | Description |
|---|---|---|
| FMXIN001 4 mg Naloxone microspheres powder, | EXPERIMENTAL | Naloxone powder nasal spray from Nasus Pharma, Israel |
| Narcan® 4 mg/0.1 mL nasal spray | ACTIVE_COMPARATOR | Naloxone solution nasal spray from Adapt Pharma, Inc., USA |
| Name | Type | Description |
|---|---|---|
| Nasus Pharma FMXIN001 | COMBINATION_PRODUCT | A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device |
| Nasal Naloxone liquid spray | COMBINATION_PRODUCT | A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device |
Inclusion Criteria: 1. Healthy, non-smoking, male and female subjects, 18 years of age or older. 2. BMI ≥18 and ≤30 kg/m2. 3. Females may be of childbearing or non-childbearing potential: * Childbearing potential: o Physically capable of becoming pregnant * Non-childbearing potential: ...