Conditions: Healthy
Keywords: Volunteer Pharmacokenetics (PK) (plasma and Cerebrospinal Fluid [CSF])
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 13
Healthy volunteers: yes

Brief summary:
A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and bioavailability study in healthy volunteers.

Detailed description:
An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually Versus Intravenously in Healthy Volunteers

Arms:
arm 1: nasal fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute.

Will be administered on either study day 1 or 3 per protocol and randomization. arm 2: sublingual fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue.

Will be administered on either study day 1 or 3 per protocol and randomization. arm 3: IV fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes.

Will be administered on study day 5 per protocol.

Interventions: intervention 1: Fentanyl
Intervention descriptions: intervention 1: Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl

Protocol document: