Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
Information source: Mallinckrodt
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Controlled-Release Oxycodone Hydrochloride 40 mg tablet (Drug); OxyContin® 40 mg tablet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mallinckrodt Official(s) and/or principal investigator(s): Herbert Neuman, MD, Study Director, Affiliation: Mallinckrodt
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.
Clinical Details
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 Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence based on AUCf, AUCinf and Cmax
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
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.
Locations and Contacts
Bio-Kinetic Clinical Applications, Springfield, Missouri 65801, United States
Additional Information
Starting date: April 2005
Last updated: February 27, 2009
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