Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 mg Tablets

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

The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 15 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 15 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.

Condition Intervention Phase
Drug: Oxycodone hydrochloride tablet 15 mg
Drug: Roxicodone™ tablet 15 mg
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 Relative Bioavailability of an Immediate Release Test Tablet Formulation of Oxycodone Hydrochloride (15 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Roxicodone™, 15 mg Tablet, Roxane Laboratories, 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 36 hours. Washout period between doses was 7 days. ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: February 2003
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Oxycodone hydrochloride tablet 15 mg
Drug: Oxycodone hydrochloride tablet 15 mg
Oxycodone hydrochloride tablet 15 mg, single dose fasting
Active Comparator: B
Roxicodone™ tablet 15 mg
Drug: Roxicodone™ tablet 15 mg
Roxicodone™ tablet 15 mg, single dose fasting


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 alcohol, drug, or narcotic abuse or dependence.
  2. Chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
  3. History or presence of major organ dysfunction.
  4. History of cardiac disorder, malignancy, stroke, or diabetes; 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 conditions.
  8. History of conditions that 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 any opiate agonists.
  9. Administration of any other investigational drug during the 30 days prior to enrollment into the study.
  10. Subjects who smoke or have a history of smoking, or use nicotine-containing products.
  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.
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Please refer to this study by its identifier: NCT00853320

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

No publications provided

Responsible Party: Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt Identifier: NCT00853320     History of Changes
Other Study ID Numbers: 8515-02-779
Study First Received: February 26, 2009
Last Updated: February 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mallinckrodt:
Healthy Subjects

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on March 26, 2015