- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864357
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-fasting Conditions
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-Fasting Conditions
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Missouri
-
St. Charles, Missouri, United States, 63301
- Gateway Medical Research, Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All subjects selected for this study will be at least 18 years of age.
- 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:
- 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.]
- 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.
- Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
- 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.
- Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
- 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.
- 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.
- 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.
- Subjects with positive HIV or hepatitis screen will not be allowed to participate in the study.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose
|
A: Experimental SSubjects received Actavis formulated products under non-fasting conditions
Other Names:
|
Active Comparator: B
COMBONOX® tablets, single dose
|
B: Active comparator Subjects received Forest Pharmaceuticals, Inc formulated products under non-fasting conditions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate and Extend of Absorption
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher R. Longnecker,, M.D., Cetero Research, San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Analgesics, Opioid
- Narcotics
- Ibuprofen
- Oxycodone
Other Study ID Numbers
- B0605002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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