Bioavailability
Conditions
Brief 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.
Interventions
A single dose of fentanyl, 400 mcg per sublingual spray
DRUGFentanyl Citrate Injection (FCI)
A single dose of fentanyl citrate, 100 mcg per intramuscular injection
DRUGNaltrexone
Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.
Sponsors
INSYS Therapeutics Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) by mode of administration | within 36 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve [AUC(last)] by mode of administration | prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose |
| Area under the curve extrapolated to infinity [AUC(inf)] by mode of administration | prior to the intial dose, at 5, 10, 20, 30, and 40 minutes postdose, and at 1.0, 1.25, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 36 hours post-dose |
Countries
United States
Outcome results
None listed