Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions
NCT ID: NCT02138396
Last Updated: 2014-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2014-01-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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FSS first, then FCI
At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single dose of fentanyl sublingual spray (FSS) at the first visit. After a washout period of at least seven days, they receive a single intramuscular fentanyl citrate injection (FCI) at the second treatment visit.
Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
Fentanyl Citrate Injection (FCI)
A single dose of fentanyl citrate, 100 mcg per intramuscular injection
Naltrexone
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.
FCI first, then FSS
At each of two treatment visits participants fast for 10 hours before dosing, and receive naltrexone before and after dosing. Participants in this group receive a single intramuscular fentanyl citrate injection (FCI) at the first visit. After a washout period of at least seven days, they receive a single dose of fentanyl sublingual spray (FSS) at the second treatment visit.
Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
Fentanyl Citrate Injection (FCI)
A single dose of fentanyl citrate, 100 mcg per intramuscular injection
Naltrexone
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.
Interventions
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Fentanyl Sublingual Spray (FSS)
A single dose of fentanyl, 400 mcg per sublingual spray
Fentanyl Citrate Injection (FCI)
A single dose of fentanyl citrate, 100 mcg per intramuscular injection
Naltrexone
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good access to veins on both sides
* Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Exclusion Criteria
* Presence or history of oral disease, irritation or piercings
* Allergy or adverse response to fentanyl, naltrexone, or related drugs
* Tattoos, scarring, or other skin abnormality at planned injection sites
* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
18 Years
55 Years
ALL
Yes
Sponsors
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INSYS Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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George J Atiee, MD
Role: PRINCIPAL_INVESTIGATOR
Worldwide Clinical Trials Early Phase Services, LLC
Locations
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Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, United States
Countries
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Other Identifiers
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INS-13-019
Identifier Type: -
Identifier Source: org_study_id