NCT02576353

Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

A Phase 1, Open-label, Randomized, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The secondary objective is to determine the safety and tolerability of fentanyl sublingual spray in opioid naive subjects.

Conditions

• Pharmacokinetics and Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Fentanyl	Fentanyl Sublingual Spray (FSS)
DRUG	Fentanyl Citrate	Fentanyl Citrate IV (FCIV)

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-10-15
• Last updated: 2015-12-02

Locations

1 site across 1 country: United States