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Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

NCT02138396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-12-12

No results posted yet for this study

Summary

The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection.

Conditions

  • Bioavailability

Interventions

DRUG

Fentanyl Sublingual Spray (FSS)

A single dose of fentanyl, 400 mcg per sublingual spray

DRUG

Fentanyl Citrate Injection (FCI)

A single dose of fentanyl citrate, 100 mcg per intramuscular injection

DRUG

Naltrexone

Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • George J Atiee, MD · Worldwide Clinical Trials Early Phase Services, LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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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 NCT02138396 on ClinicalTrials.gov