- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653315
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
April 9, 2008 updated by: Par Pharmaceutical, Inc.
To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions.
To compare the relative bioavailability of Kali and Ortho-McNeil's
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy Males and females between 18 and 45 years of age inclusive
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.
Exclusion Criteria:
- Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
- Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
- This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
- Tobacco use(>5 cigarettes per day)in the 3 months prior to study dosing.
- If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
- Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
- Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
- females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Subjects received kali product under fasting conditions
|
Tablets, 37.5mg/325mg, single dose
Other Names:
|
Active Comparator: B
Subjects received Ortho-Mcneil product under fasting conditions
|
Tablets, 37.5mg/325mg
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ralph Scallion, AAI Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Primary Completion (Actual)
August 1, 2002
Study Completion (Actual)
August 1, 2002
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 4, 2008
Study Record Updates
Last Update Posted (Estimate)
April 11, 2008
Last Update Submitted That Met QC Criteria
April 9, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAI-US-121
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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