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OpenTrials
Completed

NCT Number: NCT02138396

Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

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.

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Key information

Conditions

Bioavailability

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Sublingual Spray (FSS)

Drug

A single dose of fentanyl, 400 mcg per sublingual spray

Other names: Subsys®

Fentanyl Citrate Injection (FCI)

Drug

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

Naltrexone

Drug

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

Primary outcomes

  1. Maximum concentration (Cmax) by mode of administration

    Time frame: within 36 hours after dosing

Secondary outcomes

  1. Area under the concentration-time curve [AUC(last)] by mode of administration

    Time frame: 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

  2. Area under the curve extrapolated to infinity [AUC(inf)] by mode of administration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

INSYS Therapeutics Inc

Industry

Registry information

Official study title

Single-Dose, Open-Label, Two-Period, Two-Treatment, Two-Sequence Crossover Exploratory Bioavailability Study of Subsys® (Fentanyl Sublingual Spray), 400 mcg, and Fentanyl Citrate Injection 2 mL x 0.05 mg/mL (Total Dose 100 mcg) Under Fasted Conditions

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 14, 2014
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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