A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Fasting Conditions

NCT ID: NCT00864526

Last Updated: 2010-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2006-10-31

Brief Summary

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 fasting conditions.

Detailed Description

Study Type: Interventional Study Design: Single dose randomized, two-period, two-treatment, two-sequence crossover study under 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 Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose

Group Type: EXPERIMENTAL

Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose

Intervention Type: DRUG

A: Experimental SSubjects received Actavis formulated products under fasting conditions

B

COMBONOX® tablets, single dose

Group Type: ACTIVE_COMPARATOR

COMBONOX® tablets, single dose

Intervention Type: DRUG

B: Active comparator Subjects received Forest Pharmaceuticals, Inc formulated products under fasting conditions

Interventions

Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose

A: Experimental SSubjects received Actavis formulated products under fasting conditions

Intervention Type: DRUG

COMBONOX® tablets, single dose

B: Active comparator Subjects received Forest Pharmaceuticals, Inc formulated products under fasting conditions

Intervention Type: DRUG

Other Intervention Names

Oxycodone; Ibuprofen; Oxycodone; Ibuprofen

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Christopher R. Longnecker,, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

Gateway Medical Research, Inc

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

B0605001

Identifier Type: -

Identifier Source: org_study_id