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

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ClinicalTrials.gov Identifier: NCT00853892
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : September 9, 2016
Sponsor:
Information provided by:
Mallinckrodt

Tracking Information
First Submitted Date  ICMJE February 27, 2009
First Posted Date  ICMJE March 2, 2009
Last Update Posted Date September 9, 2016
Study Start Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
Official Title  ICMJE 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 Fasting Conditions
Brief Summary 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 fasting conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Controlled-Release Oxycodone Hydrochloride 40 mg tablet
    Controlled-Release Oxycodone Hydrochloride 40 mg, single dose fasting
  • Drug: OxyContin® 40 mg tablet
    OxyContin® 40 mg tablet, single dose fasting
Study Arms  ICMJE
  • Experimental: A
    Controlled-Release Oxycodone Hydrochloride 40 mg tablet
    Intervention: Drug: Controlled-Release Oxycodone Hydrochloride 40 mg tablet
  • Active Comparator: B
    OxyContin® 40 mg tablet
    Intervention: Drug: OxyContin® 40 mg tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2009)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00853892
Other Study ID Numbers  ICMJE 0595-05-812
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt
Study Sponsor  ICMJE Mallinckrodt
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mallinckrodt
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP