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A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00834288
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : October 19, 2009
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.

Tracking Information
First Submitted Date  ICMJE January 30, 2009
First Posted Date  ICMJE February 3, 2009
Results First Submitted Date  ICMJE April 8, 2009
Results First Posted Date  ICMJE October 19, 2009
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE June 2003
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss) [ Time Frame: 24 hours (day 5) ]
Area under the plasma concentration versus time data pairs over 24 hours (24h) at steady state, on day 5. ss = steady state. AUCss is also known as AUCtau.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
Area under the plasma concentration vs time data pairs (AUCss)
Change History Complete list of historical versions of study NCT00834288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
  • Maximum Plasma Concentration at Steady State(Cmax,ss) [ Time Frame: 24 hours (day 5) ]
    Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.
  • Minimum Plasma Concentration at Steady State(Cmin,ss) [ Time Frame: 24 hours (day 5) ]
    Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.
  • Time to Peak Exposure (Tmax) [ Time Frame: 24 hours (day 5) ]
    Time to peak exposure over 24 hours (24h) at steady state on day 5.
  • Percentage Peak-trough Fluctuation (% PTF) [ Time Frame: 24 hours (day 5) ]
    Percentage peak-trough fluctuation over 24 hours (24h) at steady state on day 5. Percent peak-to-trough fluctuation is calculated as (Cmax - Cmin)/Cav*100, where Cmax is the maximum observed concentration, Cmin is the minimum observed concentration and Cav is the average concentration over 24 hours (where Cav = AUCss/24).
  • Percentage Swing [ Time Frame: 24 hours (day 5) ]
    Percentage swing is a pharmacokinetic parameter recommended by the FDA for submission and is calculated as follows:((Cmax,ss - Cmin,ss)/Cmin,ss)*100. It was calculated over 24 hours on day 5. Where: Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.
  • Half-value Duration (HVD) [ Time Frame: 24 hours (day 5) ]
    Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.
  • Plateau Time (T75%Cmax) [ Time Frame: 24 hours (day 5) ]
    Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2009)
  • Maximum concentration (Cmax,ss)
  • Minimum concentration (Cmin,ss)
  • Time to Peak Exposure (Tmax)
  • Percentage Peak-trough Fluctuation (% PTF)
  • % SWING
  • Half-value Duration (HVD)
  • Plateau Time (T75%Cmax)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
Official Title  ICMJE A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
Brief Summary The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure) after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference product) and 200 mg 24-hourly at 07:30 (test product), were compared.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy Subjects
  • Pharmacokinetics
  • Bioavailability
Intervention  ICMJE
  • Drug: Tramadol HCl
    1x200 mg Tramadol HCl OAD tablet daily
  • Drug: Tramadol HCl
    1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
Study Arms  ICMJE
  • Experimental: 1: 1x200 mg Tramadol HCl OAD tablet daily
    Intervention: Drug: Tramadol HCl
  • Active Comparator: 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
    Intervention: Drug: Tramadol HCl
Publications * Karhu D, Fradette C, Potgieter MA, Ferreira MM, Terblanché J. Comparative pharmacokinetics of a once-daily tramadol extended-release tablet and an immediate-release reference product following single-dose and multiple-dose administration. J Clin Pharmacol. 2010 May;50(5):544-53. doi: 10.1177/0091270009347673. Epub 2010 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2009)
26
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, non-smoking, male and female subjects between the ages 18 to 55 years (inclusive).
  • Body mass within 10% of the ideal mass in relation to height and age, according to the BMI
  • Body mass not less than 70 kg.
  • Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results with the "normal ranges" for the relevant laboratory tests (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
  • Normal ECG and vital signs, or abnormalities which the clinical investigator did not consider a disqualification for participation in the study
  • Willingness to undergo a pre-study physical examination and pre- and post-study laboratory investigations.
  • Ability to comprehend and willingness to sign both statements of Informed Consent (for screening and phase-related procedures)
  • Non-smokers or past smokers who stopped smoking at least three months before entering the study
  • For females, the following conditions had to be met:

    • had been postmenopausal for at least two years, or
    • had been surgically sterilized, or
    • was of childbearing potential, and all of the following conditions were met:
    • had a normal menstrual flow within one month before study entry, and
    • had negative urine pregnancy test at screening and on Day 1 of each study period. If the result of either test was positive, the subject would have been excluded from the study before receiving study medication.
    • had to agree to use an accepted method of contraception. The subject had to agree to continue with the same method throughout the study. Hormonal contraceptives were not allowed.

Exclusion Criteria:

  • Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
  • History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
  • Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this would not have affected the outcome of the study in the opinion of the clinical investigator. Use of hormonal contraceptives agents by females was not allowed.
  • Participation in another study with an experimental drug within 8 weeks before the first administration of study medication.
  • Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system with evidence to this effect.
  • Major illness during the 3 months before commencement of the screening period.
  • History of hypersensitivity to the study drug or any related drugs.
  • History of bronchial asthma.
  • History of epilepsy.
  • Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
  • Donation or loss of blood equal to or exceeding 500 ml during the 8 weeks before the first administration of study medication.
  • Diagnosis of hypotension made during the screening period.
  • Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
  • Resting pulse of > 100 beats per minutes or < 45 beats per minutes during the screening period, either supine or standing.
  • Positive testing for hepatitis B antigen.
  • Significant liver disease, defined as active hepatitis or elevated liver enzymes (e.g., AST, ALT) > 3 times the upper boundary of the normal range.
  • Positive urine screen for drugs of abuse.
  • Positive urine screen for tobacco use.
  • History of marijuana, barbiturates, amphetamine, or narcotic abuse within 12 months prior to study start.
  • Previous participation in a tramadol study.
  • pregnancy or lactation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00834288
Other Study ID Numbers  ICMJE MDT1-009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Labopharm Inc.
Study Sponsor  ICMJE Labopharm Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Labopharm Inc.
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP