NCT01173627

Bioequivalence of a Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to Actiq® 400 mcg, Cephalon, Inc.

An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Bioequivalence of an Oral Transmucosal Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Actiq 400 mcg, Cephalon, Inc.) in Normal Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.

Detailed description

Fentanyl is an opioid analgesic with pharmacological effects similar to morphine. Fentanyl interacts predominately with the opioid µ-receptor. In clinical settings, fentanyl exerts its principal pharmacologic effects on the central nervous system. The fentanyl citrate oral transmucosal troche, Actiq (Cephalon, Inc.), is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to prior therapy for their underlying persistent cancer pain.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Test fentanyl citrate 400 mcg troche	Test fentanyl citrate 400 mcg troche administered as a single dose under fasted conditions
DRUG	Actiq 400 mcg	Actiq 400 mcg administered as a single dose under fasted conditions

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2010-08-02
• Last updated: 2016-10-19

Locations

1 site across 1 country: United States