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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01173627
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : October 19, 2016
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: Test fentanyl citrate 400 mcg troche Drug: Actiq 400 mcg Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

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Arm Intervention/treatment
Experimental: A - Test fentanyl citrate 400 mcg troche
Test fentanyl citrate 400 mcg troche
Drug: Test fentanyl citrate 400 mcg troche
Test fentanyl citrate 400 mcg troche administered as a single dose under fasted conditions

Active Comparator: B - Actiq 400 mcg
Actiq 400 mcg
Drug: Actiq 400 mcg
Actiq 400 mcg administered as a single dose under fasted conditions

Primary Outcome Measures :
  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%]. [ Time Frame: 30 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Positive test results for drugs of abuse or alcohol.
  • Subjects who have taken prescription drugs, except hormonal contraception, within 14 days or over-the-counter medications (including herbal preparations) within 7 days prior to study drug administration except for standard daily dose multivitamins, which are excluded after check-in to Period 2.
  • Any subject experiencing adverse events to the -13 and/or -1 hour doses of naltrexone, that in the investigator's opinion, are indicative of possible previous opioid use/abuse, or that would prevent tolerance of additional doses of naltrexone, will be withdrawn from the study prior to dosing with fentanyl.
  • Subjects with dental braces or partial dentures.
  • Subjects presenting with a history of gum disease.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01173627

United States, North Dakota
PRACS Institute, Ltd
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Study Director: Herbert Neuman, MD Mallinckrodt

Responsible Party: Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt Identifier: NCT01173627     History of Changes
Other Study ID Numbers: 9204-06-840
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Mallinckrodt:

Additional relevant MeSH terms:
Citric Acid
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action