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

NCT01173627 | Completed Phase 1

• 1 other identifier: 9204-06-840
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Bioequivalence; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Average bioequivalence is established if the 90% confidence interval on the ratio of formulation averages for AUCt, AUCinf, and Cmax are contained in the interval [80%, 125%].

  30 hours

Study Arms (2)

A - Test fentanyl citrate 400 mcg troche

EXPERIMENTAL

Test fentanyl citrate 400 mcg troche

Drug: Test fentanyl citrate 400 mcg troche

B - Actiq 400 mcg

ACTIVE COMPARATOR

Actiq 400 mcg

Drug: Actiq 400 mcg

Interventions

Test fentanyl citrate 400 mcg troche DRUG

Test fentanyl citrate 400 mcg troche administered as a single dose under fasted conditions

A - Test fentanyl citrate 400 mcg troche

Actiq 400 mcg DRUG

Actiq 400 mcg administered as a single dose under fasted conditions

B - Actiq 400 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant, non-lactating females, 18 years of age or older with a minimum body weight of 120 pounds and a body mass index (BMI) between 19 and 29 inclusive.
• Female subjects must be postmenopausal for at least one year, surgically sterile, or using a reliable method of contraception (oral, transdermal, or injectable hormonal contraceptive; condom with spermicide; IUD; abstinence, etc.) for at least 30 days prior to and for the duration of study participation.
• Normal, healthy status confirmed by required screening assessments.
• Subjects must be able to provide written consent and agree to abide by the study requirements.
• Subjects must be able to demonstrate they understand and can perform the dosing procedure correctly using a placebo troche at check-in to Period 1.

You may not qualify if:

• If female, a positive pregnancy test at any time during the study, pregnant, lactating, or likely to become pregnant during the study.
• Female subjects of childbearing potential who have not used adequate forms of birth control within 30 days of dosing.
• History of conditions that might contraindicate or require caution be used in the administration of fentanyl or naltrexone, including: renal impairment, hepatobiliary or pancreatic disease, gastrointestinal obstruction, cardiac disease, obstructive pulmonary disease, acute or severe bronchial asthma, hypercarbia, elevated intracranial pressure, depleted blood volume, paralytic ileus, or hypersensitivity or idiosyncratic reaction to fentanyl, naltrexone, or any opioids.
• History of any drug allergy, hypersensitivity, or intolerance which would compromise the safety of the subject or the study.
• History of chronic alcohol, drug, or narcotic abuse, chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
• History of malignancy, stroke, or diabetes; cardiac, renal, liver, and pulmonary disease.
• History of anxiety, tension, severe agitation, psychiatric disorders, psychosis, or mental depression requiring hospitalization, psychotherapy, and/or medication.
• History or diagnosis of epilepsy or other seizure disorder.
• History of abdominal and/or pelvic surgery within the last 5 years, except elective surgical sterilization.
• History of acute abdominal conditions or gastrointestinal disease including, but not limited to, peptic ulcer, diverticulitis, bowel obstructions, adhesions, ileus, gastritis, and chronic diarrhea.
• Subjects presenting with acute illness.
• Administration of any other investigational drug during the 30 days prior to study entry.
• Subjects who have smoked or used nicotine-containing products within 6 months prior to study entry.
• Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
• Positive test results for HIV, hepatitis B, or hepatitis C.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (1)

PRACS Institute, Ltd

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Herbert Neuman, MD

  Mallinckrodt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: August 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (1)