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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

This study has been completed.
Sponsor:
Information provided by:
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT00911742
First received: April 8, 2009
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Pain
 Drug: Tramadol Contramid OAD
Drug: Zytram
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Labopharm Inc.:

Primary Outcome Measures:
  • AUC(0-t) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

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

    h=hour


  • AUC (0-∞) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

    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


  • Cmax [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Maximum plasma concentration


Secondary Outcome Measures:
  • t1/2 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Apparent terminal elimination half-life

  • Tmax [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Time to maximum plasma concentration


Enrollment: 26
Study Start Date: February 2004
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Tramadol Contramid Once A Day Drug: Tramadol Contramid OAD
1 Tramadol Contramid OAD 200 mg tablet as a single dose
Other Name: Tramadol Contramid OAD
Active Comparator: 2 Zytram (R) Drug: Zytram
1 Zytram 200 mg tablet as a single dose
Other Name: Zytram

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Vice-President Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00911742     History of Changes
Other Study ID Numbers: MDT1-012
Study First Received: April 8, 2009
Results First Received: April 8, 2009
Last Updated: April 24, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Tramadol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 21, 2013