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Fed Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension

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.
ClinicalTrials.gov Identifier: NCT00853190
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : October 19, 2016
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone polistirex compared to an equivalent oral dose of a commercially available extended release oral suspension of chlorpheniramine polistirex/hydrocodone polistirex (Tussionex® Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in a test group of healthy subjects under fed conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule Drug: 5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Bioequivalence of an Extended Release Test Capsule Formulation of Chlorpheniramine Polistirex and Hydrocodone Polistirex Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Tussionex® Pennkinetic® Extended Release Oral Suspension, Celltech Pharmaceuticals, Inc.) in Normal Human Subjects Under Fed Conditions
Study Start Date : September 2003
Primary Completion Date : October 2003
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Chlorpheniramine polistirex/hydrocodone polistirex extended release capsule
Drug: Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule
Chlorpheniramine polistirex/hydrocodone polistirex extended release capsule, single dose with food
Active Comparator: B
Tussionex® Pennkinetic® Extended Release Oral Suspension
Drug: 5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension
Tussionex® Pennkinetic® Extended Release Oral Suspension, single dose with food


Outcome Measures

Primary Outcome Measures :
  1. Bioequivalence based on AUCf, AUCinf and Cmax [ Time Frame: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 72 hours. Washout period between doses was 7 days. ]

Eligibility Criteria

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

Inclusion Criteria:

  1. Males or non-pregnant, non-lactating females, 18 years of age or older.
  2. Female subjects must be postmenopausal for at least one year, or surgically sterile, or practicing adequate non-hormonal contraception for at least 3 months prior to and for the duration of study participation. All female subjects will undergo a pregnancy test at screening and at check-in to the clinical study site for every dosing period. The results of the test must be negative for continued participation.
  3. Weight must be within 15% of the ideal weight for height and frame, as adopted by the Metropolitan Life Insurance Co., 1993.
  4. Qualifying subjects must be in good health and physical condition as determined by a screening medical history obtained within 30 days prior to study start. Subjects should not present with a history of significant past illness expected to affect the investigation.
  5. The normal status of subjects will be confirmed by the following procedures:

    1. Laboratory tests (chemistry, hematology, urinalysis)
    2. Human immunodeficiency virus (HIV), hepatitis, alcohol, and "drugs of abuse" testing will be done for screening purposes only. Results of the HIV, hepatitis, and "drugs of abuse" tests must be negative or non-reactive for subjects to qualify for the study.
    3. Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. This ECG must be interpreted by appropriately trained and experienced medical personnel. A subject with an ECG that is not within normal range does not qualify, unless specifically accepted (with comment) by the investigator.
  6. Subjects must be able to provide written consent and agree to abide by the study requirements (including consuming the entire standardized breakfast).

Exclusion Criteria:

  1. History of chronic alcohol, drug, or narcotic abuse.
  2. Chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
  3. History or presence of major organ dysfunction.
  4. History of malignancy, stroke, or diabetes; cardiac, renal, liver, pulmonary, or severe gastrointestinal disease; or other serious illness.
  5. History of anxiety, tension, severe agitation, psychosis, or mental depression.
  6. Family history or diagnosis of epilepsy or other seizure disorder.
  7. History of glaucoma.
  8. History of acute abdominal conditions.
  9. History of conditions which might contraindicate or require caution be used in the administration of chlorpheniramine/hydrocodone, including: history of renal impairment, hepatic or biliary tract disease, inflammatory bowel disease, ulcerative colitis, constipation, diarrhea, gastrointestinal obstruction or ileus, cardiac disease, hypertension, bladder obstruction, pain or difficulty passing urine, systemic lupus erythematosus, head trauma, increased intracranial pressure, pulmonary disease, asthma, or history of hypersensitivity to any opiate agonists or antihistamines.
  10. Administration of any other investigational drug during the 30 days prior to enrollment into the study.
  11. Subjects who smoke or have a history of smoking, or use nicotine-containing products.
  12. Subjects who have donated blood within 30 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
  13. Subjects presenting with acute illness.
  14. Subjects who must wear contact lenses during the study.
  15. Subjects who have taken prescription drugs within 14 days or over-the-counter medications (including herbal preparations) within 7 days prior to dosing except for standard daily dose multivitamins.
Contacts and Locations

Information from the National Library of Medicine

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 ClinicalTrials.gov identifier (NCT number): NCT00853190


Locations
United States, Missouri
Gateway Medical Research
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Herbert Neuman, MD Mallinckrodt
More Information

Responsible Party: Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt
ClinicalTrials.gov Identifier: NCT00853190     History of Changes
Other Study ID Numbers: 8867-03-791
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Mallinckrodt:
Healthy Subjects

Additional relevant MeSH terms:
Hydrocodone
Chlorpheniramine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents