A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864357
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

To compare the relative bioavailability of oxycodone HCl 5 mg / ibuprofen 400 mg tablets (Actavis Elizabeth LLC, Lot No. PI-1565) with that of COMBONOX® tablets (Forest Pharmaceuticals, Inc., Lot No. 010550) in healthy adult volunteers under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose
Drug: COMBONOX® tablets, single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose
Drug: Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose
A: Experimental SSubjects received Actavis formulated products under non-fasting conditions
Other Names:
  • Oxycodone
  • Ibuprofen
Active Comparator: B
COMBONOX® tablets, single dose
Drug: COMBONOX® tablets, single dose
B: Active comparator Subjects received Forest Pharmaceuticals, Inc formulated products under non-fasting conditions
Other Names:
  • Oxycodone
  • Ibuprofen

Detailed Description:

Study Type: Interventional Study Design: Single dose randomized, two-period, two-treatment, two-sequence crossover study under non-fasting conditions comparing equal doses of the test and reference products.

Official Title: A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

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

Inclusion Criteria:

  1. All subjects selected for this study will be at least 18 years of age.
  2. Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.

Each female subject will be given a serum pregnancy test as part of the pre-study screening process.

At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.

Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.

Clinical laboratory measurements will include the following as a minimum:

Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).

Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.

Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.

HIV Screen: (pre-study only)

Hepatitis-B, C Screen: (pre-study only)

Drugs of Abuse Screen: (pre-study and at check-in each dosing period)

Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.

Exclusion Criteria:

  1. Subjects with a history of alcoholism or drug addiction (during past 2 years), or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study. [Subjects who have had a cholecystectomy will not be eligible unless approved by the sponsor.]
  2. Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  3. Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
  4. All subjects will have urine/saliva samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at check-in each dosing period. Subjects found to have urine/saliva concentrations of any of the tested drugs will not be allowed to participate.
  5. Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  6. Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  7. Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study dosing, or used oral hormonal contraceptives or a contraceptive transdermal patch within 14 days before dosing will not be allowed to participate.
  8. All female subjects will be screened for pregnancy prior to dosing each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  9. Subjects with positive HIV or hepatitis screen will not be allowed to participate in the study.
  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: NCT00864357

Locations
United States, Missouri
Gateway Medical Research, Inc
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Christopher R. Longnecker,, M.D. Cetero Research, San Antonio
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864357     History of Changes
Other Study ID Numbers: B0605002
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Oxycodone
Ibuprofen
Healthy subjects

Additional relevant MeSH terms:
Ibuprofen
Oxycodone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 29, 2014