Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Citric Acid; Fentanyl; Naltrexone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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