Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
naloxone AP003 · 1 trial · 1 indication
The mean naloxone plasma concentration during the two AP003 dosing periods.
The mean naloxone plasma concentration during the two Narcan dosing periods.
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of abnormal vital signs (heart rate, blood pressure, and respiration rate) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of clinically significant ECG by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of clinical laboratory changes by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of adverse events of special interest (AESI) indicating of nasal irritation (erythema, edema, and erosion) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Incidence of changes in B-SIT assessment within an AP003 period thru End of Study Visit (within 7 days after 2nd dose).
| Arm | Type | Description |
|---|---|---|
| Arm 1 Interventional Therapy | OTHER | Subjects will first receive 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device (Arm 1) before the washout period. |
| Arm 2 Reference Therapy | OTHER | Subjects will first receive 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device (reference therapy, Arm 2) before the washout period. |
| Name | Type | Description |
|---|---|---|
| 16 mg naloxone AP003 | COMBINATION_PRODUCT | 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device |
| 8 mg naloxone NARCAN Nasal Spray | COMBINATION_PRODUCT | 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device |
Inclusion Criteria: * Are able to consent and freely provide informed consent. * Females and males 18-55 years of age, inclusive. * Have a body mass index (BMI) less than or equal to 34.0 kg/m2. * Generally healthy, in the opinion of the Investigator, based on medical history, physical examination,...