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

This study has been completed.
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00853294
First received: February 26, 2009
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

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 fasting conditions.


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 fasting
Experimental: A
Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate 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 fasting

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853294

Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Herbert Neuman, MD Mallinckrodt
  More Information

No publications provided

Responsible Party: Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt
ClinicalTrials.gov Identifier: NCT00853294     History of Changes
Other Study ID Numbers: 8867-03-790
Study First Received: February 26, 2009
Last Updated: February 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mallinckrodt:
Healthy Subjects
Bioequivalence

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

ClinicalTrials.gov processed this record on July 20, 2014