MedTrace Logo

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

NCT02576353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-12-02

No results posted yet for this study

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

DRUG

Fentanyl

Fentanyl Sublingual Spray (FSS)

DRUG

Fentanyl Citrate

Fentanyl Citrate IV (FCIV)

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Neha N Parikh · INSYS Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576353 on ClinicalTrials.gov