Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg

Study Overview
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Brief Summary
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The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.

Official Title
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Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg OAD Formulation Versus Zytram® 200 mg

Conditions
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Pain

Intervention / Treatment
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* Drug: Tramadol Contramid OAD
* Drug: Zytram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects of either gender Age between 18 and 45 years Body mass index between 19 and 27kg/m2 Normal medical history Normal or no clinically significant physical examination findings Normal or no clinically significant findings in analytical tests Negative hepatitis B, hepatitis C or HIV serology Negative drugs of abuse in urine Negative pregnancy test in females The subject understands and accepts the study procedures and grants in writing his/her informed consent Exclusion Criteria: Did not fulfill the inclusion criteria Organic disorders or underwent major surgery, within 90 days before study screening Psychiatric history Alcohol drink intake greater than 30gr/day Cigarette smoking greater than 10 cigarettes/day Excessive consumption of food or beverages containing xanthines (more than five units of coffee, tea or cola per day) Medical treatment within 30 days before screening, and/or any medication 7 days before starting the study Participation in other clinical study or donate blood within 90 days before starting this study Antecedents of gastric, hepatic, renal and other kind of disorder that could affect ADME (absorption, distribution, metabolism or excretion of the study drug) Hepatitis B, hepatitis C or HIV positive serology Pregnant or breastfeeding Clinically relevant hypersensitivities (in particular to drugs) Woman taking oral contraceptive drugs Incapable of communicating and cooperating with investigators

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Tramadol Contramid Once A Day<br> | Drug: Tramadol Contramid OAD<br>* 1 Tramadol Contramid OAD 200 mg tablet as a single dose<br>|
| Active Comparator: 2 Zytram (R)<br> | Drug: Zytram<br>* 1 Zytram 200 mg tablet as a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-t) | Area under the plasma concentration versus time curve to the last measured concentration. h=hour | 48 hours | 
| AUC (0-∞) | The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL. h=hours | 48 hours | 
| Cmax | Maximum plasma concentration | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t1/2 | Apparent terminal elimination half-life | 48 hours | 
| Tmax | Time to maximum plasma concentration | 48 hours |