drugset / Trial / NCT05377255
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
RandomizedCrossoverOpen-labelTreatment
Summary
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
Timeline
- Start
- 2022-03-28
- Primary completion
- 2022-05-10
- Completion
- 2022-05-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naloxone | Small molecule | 8 mg | Intranasal |
| Subject | Naloxone | Small molecule | 16 mg | Intranasal |