Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

Completed · Not applicable

Conditions studied: Bioavailability

In brief

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.

Key facts

Study ID: NCT02138396
Run by: INSYS Therapeutics Inc
People needed: 12
Starts: 2014-01-01
Expected to finish: 2014-01-01
Last updated by the study team: 2014-12-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Meets protocol-specified criteria for qualification and contraception
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

You may not qualify if…

Intolerance to venipuncture or injections
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

Where it is running

Worldwide Clinical Trials Early Phase Services, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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