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

NCT01173627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-10-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Herbert Neuman, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01173627 on ClinicalTrials.gov