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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

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ClinicalTrials.gov Identifier: NCT00911742
Recruitment Status : Completed
First Posted : June 2, 2009
Results First Posted : June 2, 2009
Last Update Posted : April 27, 2012
Information provided by:
Labopharm Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Tramadol Contramid OAD Drug: Zytram Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg OAD Formulation Versus Zytram® 200 mg
Study Start Date : February 2004
Primary Completion Date : March 2004
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol
U.S. FDA Resources

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

Primary Outcome Measures :
  1. AUC(0-t) [ Time Frame: 48 hours ]

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


  2. 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.


  3. Cmax [ Time Frame: 48 hours ]
    Maximum plasma concentration

Secondary Outcome Measures :
  1. t1/2 [ Time Frame: 48 hours ]
    Apparent terminal elimination half-life

  2. Tmax [ Time Frame: 48 hours ]
    Time to maximum plasma concentration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Vice-President Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00911742     History of Changes
Other Study ID Numbers: MDT1-012
First Posted: June 2, 2009    Key Record Dates
Results First Posted: June 2, 2009
Last Update Posted: April 27, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents