Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

Study Overview
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Brief Summary
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To compare the relative bioavailability of Kali and Ortho-McNeil's

Detailed Description
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To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg

Official Title
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To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions.

Conditions
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To Determine Bioequivalence Under Fasting Conditions

Intervention / Treatment
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* Drug: Tramadol APAP
* Drug: Ultracet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subjects received kali product under fasting conditions | Drug: Tramadol APAP<br>* Tablets, 37.5mg/325mg, single dose<br>* Other names: Ultracet;|
| Active Comparator: B<br>Subjects received Ortho-Mcneil product under fasting conditions | Drug: Ultracet<br>* Tablets, 37.5mg/325mg<br>* Other names: Tramadol APAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and Extend of absorption |  | 24 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Tramadol APAP, fasting