Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets

This study has been completed.
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00853268
First received: February 27, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group of healthy subjects under fed conditions.


Condition Intervention Phase
Healthy
Drug: Controlled-Release Oxycodone Hydrochloride 40 mg
Drug: OxyContin® 40 mg tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (OxyContin® 40 mg, Purdue Pharma L.P.) in Normal Human Subjects Under Fed 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 36 hours. Washout period between doses was 7 days. ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: April 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Controlled-Release Oxycodone Hydrochloride 40 mg tablet
Drug: Controlled-Release Oxycodone Hydrochloride 40 mg
Controlled-Release Oxycodone Hydrochloride 40 mg, single dose with food
Active Comparator: B
OxyContin® 40 mg tablet
Drug: OxyContin® 40 mg tablet
OxyContin® 40 mg tablet, single dose with food

  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, 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., 1999.
  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 (serum chemistry, hematology, urinalysis). A subject with laboratory values that are not within the clinical laboratory's reference range does not qualify, unless specifically accepted (with comment) by the investigator.
    2. Human immunodeficiency virus (HIV), drugs of abuse, alcohol, and hepatitis B and C testing will be performed at screening. Results of these tests must be negative or non-reactive for subjects to qualify for the study. At each check-in to the study site, a urine drug screen will be performed that must be negative for continued participation.
    3. Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects at screening. Appropriately trained and experienced medical personnel must interpret this ECG. 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 acute abdominal or pelvic conditions.
  8. History of conditions which might contraindicate or require caution be used in the administration of oxycodone, including renal impairment, hepatobiliary or pancreatic disease, GI obstruction, cardiac disease, obstructive pulmonary disease, acute or severe bronchial asthma, hypercarbia, elevated intracranial pressure, depleted blood volume, paralytic ileus, or allergy to oxycodone, or history of hypersensitivity to any opiate agonist
  9. Administration of any other investigational drug during the 30 days prior to enrollment into the study.
  10. Subjects who have smoked or used nicotine-containing products within 6 months prior to study entry.
  11. Subjects who have donated blood within 30 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
  12. Subjects presenting with acute illness.
  13. 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.
  14. Subjects who have a positive Narcan® challenge.
  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: NCT00853268

Locations
United States, Missouri
Bio-Kinetic Clinical Applications
Springfield, Missouri, United States, 65801
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: NCT00853268     History of Changes
Other Study ID Numbers: 0595-05-813
Study First Received: February 27, 2009
Last Updated: February 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mallinckrodt:
Healthy Subjects
Bioequivalence

Additional relevant MeSH terms:
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 22, 2014