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A Two-Period, Randomized, Open-Label, Crossover Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK) study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray using two dose levels
Details
| Lead sponsor | Acorda Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 15 |
| Start date | 2016-01 |
| Completion | 2016-06 |
Conditions
- Healthy
Interventions
- diazepam nasal spray
Primary outcomes
- Maximum measured plasma concentration (Cmax) — within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
- Area under the concentration curve from time 0 to the concentration at 24 hours (AUC0-24) — within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
- Area under the concentration curve from time 0 to infinity (AUCinf) — within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
- Apparent total body clearance of drug from plasma (CL/F) — within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Countries
United States