Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets

• ClinicalTrials.gov Identifier: NCT00853216
• Recruitment Status: Completed
• First Posted: March 2, 2009
• Last Update Posted: October 19, 2016
• Sponsor: Mallinckrodt
• Information provided by: Mallinckrodt

Tracking Information

• First Submitted Date: February 26, 2009
• First Posted Date: March 2, 2009
• Last Update Posted Date: October 19, 2016
• Study Start Date: January 2003
• Actual Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 26, 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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
• 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 (30 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Roxicodone™, 30 mg Tablet, Roxane Laboratories, Inc.) in Normal Human Subjects Under Fasting Conditions
• Brief Summary: 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 30 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
• Condition: Healthy

Intervention

• Drug: Oxycodone hydrochloride tablet 30 mg
  Oxycodone hydrochloride tablet 30 mg, single dose fasting
• Drug: Roxicodone™ tablet 30 mg
  Roxicodone™ tablet 30 mg, single dose fasting

Study Arms

• Experimental: A
  Oxycodone hydrochloride tablet 30 mg
  Intervention: Drug: Oxycodone hydrochloride tablet 30 mg
• Active Comparator: B
  Roxicodone™ tablet 30 mg
  Intervention: Drug: Roxicodone™ tablet 30 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 26, 2009): 38
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2003
• Actual Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)

Eligibility 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 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00853216
• Other Study ID Numbers: 8530-02-768
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt
• Study Sponsor: Mallinckrodt
• Collaborators: Not Provided

Investigators

• Study Director: Herbert Neuman, MD; Mallinckrodt

• PRS Account: Mallinckrodt
• Verification Date: October 2016