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Completed

NCT Number: NCT00911742

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol Contramid OAD

Drug

1 Tramadol Contramid OAD 200 mg tablet as a single dose

Zytram

Drug

1 Zytram 200 mg tablet as a single dose

Primary outcomes

  1. AUC(0-t)

    Time frame: 48 hours

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

    h=hour

  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.

    h=hours

  3. Cmax

    Time frame: 48 hours

    Maximum plasma concentration

Secondary outcomes

  1. t1/2

    Time frame: 48 hours

    Apparent terminal elimination half-life

  2. Tmax

    Time frame: 48 hours

    Time to maximum plasma concentration

Sponsors and collaborators

Lead sponsor

Labopharm Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jun 2, 2009
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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