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

April 24, 2012 updated by: Labopharm Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC(0-t)
Time Frame: 48 hours

Area under the plasma concentration versus time curve to the last measured concentration.

h=hour
48 hours
AUC (0-∞)
Time Frame: 48 hours

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
Time Frame: 48 hours
Maximum plasma concentration
48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Labopharm Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2004

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

June 1, 2009

First Posted (Estimate)

June 2, 2009

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT1-012

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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