Evaluate Safety and Tolerability and Compare Absorption/Distribution Kinetics of a Single 100 Mcg Dose of Fentanyl Sublingual Spray (Fentanyl SL Spray) in Cancer Subjects With or Without Oral Mucositis
- To compare the absorption/distribution kinetics of a single dose of fentanyl sublingual
spray in opioid-tolerant cancer patients with or without oral mucositis.
- To evaluate the safety and tolerability of this regimen.
OUTLINE: This is a multicenter study.
Patients fast for at least 8 hours before and at least 4 hours after and no water is allowed
for at least 1 hour before and at least 1 hour after study drug administration. Patients
receive a single dose of fentanyl sublingual spray while in an upright position in clinical
care recliners or beds, and remain in an upright posture for at least 4 hours after
administration. Patients are instructed not to swallow for at least 5 minutes after
administration and not to expectorate the drug.
After study drug administration, 10 blood samples are collected over a 12-hour period for
pharmacokinetic and other analyses.
Masking: Open Label, Primary Purpose: Supportive Care
Lisa J. Stearns, MD
Center for Pain and Supportive Care, PLLC
United States: Food and Drug Administration
|InSys Therapeutics, Incorporated||Scottsdale, Arizona 85258|