HealthyPhase 1NCT00834366

A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting Conditions

A Phase 1 study testing Tramadol HCl in people with Healthy, run by Labopharm Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To determine whether the test product, Labopharm Tramadol HCl Once-A-Day (OAD) 200 mg film-coated tablets, and the reference product, Labopharm Tramadol HCl OAD 200 mg uncoated tablets, are bioequivalent. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tramadol HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: No sites listed yet
Study dates: Feb 2005to Mar 2005
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects 18 to 55 years of age (inclusive).
Body mass within 10% of the ideal mass in relation to height and age, according to the Body Mass Index (BMI).
Body mass not less than 60 kg.
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the "normal ranges" for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study).
Normal electrocardiogram (ECG) and vital signs, or abnormalities which the 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.

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Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures).
Non-smoker or past smoker who stopped smoking at least 3 months before entering the study.
For females, the following conditions were to be met:
had been postmenopausal for at least 2 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 1 month before study entry, and
had negative serum pregnancy test at screening. If this test was positive, the subject was to have been excluded from the study before receiving study medication. In the rare circumstance that a pregnancy was discovered after the subjects received study drug, then every attempt must be made to follow such subjects to term, and
must agree to use an accepted method of contraception (i.e., spermicide and barrier methods or spermicide and Intrauterine Device (IUD)). The subject had to agree to continue with the same method throughout the study. Hormonal contraceptives will not be allowed.

Who cannot join

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 contraceptive agents by females were 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.
A major illness during the 3 months before commencement of the screening period.

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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 minute or <45 beats per minute 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 (aspartate aminotransferase), Alanine transaminase (ALT)) >2 times the upper boundary of the normal range.
Positive urine screen for drugs of abuse.
Positive urine screen for tobacco use (SureStepTM Smoke Check Tests and One-Step Cotinine (COT) Tests).
A serum pregnancy test (beta-hCG) either positive or not performed or lactation.
History of marijuana, barbiturate, amphetamine or narcotic abuse within 12 months prior to study start.
Participation in a tramadol study within the previous 12 months.

About this study

Conditions: Healthy
Being tested: Tramadol HCl
Keywords: Healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tramadol HClDrug
Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet or Tramadol HCl 200 mg Uncoated Tablets based on randomization schedule.

Study groups in NCT00834366
Study group	Role	What they receive
Tramadol HCl 200 mg Film-coated Tablets	Experimental	Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule. Receives: Drug: Tramadol HCl
Tramadol HCl 200 mg Uncoated Tablets	Experimental	Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule. Receives: Drug: Tramadol HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC(0-t)
Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.
Measured: 48 hours
AUC(0-Inf)
Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.
Measured: 48 hours
Cmax
Maximum plasma concentration
Measured: 48 hours

Secondary outcomes (2)

Tmax
Time to the maximum concentration
Measured: 48 hours
t1/2
Apparent terminal elimination half-life
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Mar 2005

First posted3 Feb 2009 (estimated)
Study startFeb 2005
Primary completionMar 2005
Study completionMar 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00834366
Sponsor's protocol ID: MDT1-013
Status last verified: Apr 2012
First submitted: 30 Jan 2009
Last updated: 30 Apr 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting Conditions
ClinicalTrials.gov ID: NCT00834366
Acronym / sponsor ID: MDT1-013
Conditions: Healthy
Keywords: Healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Labopharm Inc.Industry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: Mar 2005 (actual)
Study completion: Mar 2005 (actual)
First posted: 3 Feb 2009 (estimated)
Results: Posted 8 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tramadol HCl 200 mg Film-coated Tablets	Experimental	Drug: Tramadol HClSingle oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Tramadol HCl 200 mg Uncoated Tablets	Experimental	Drug: Tramadol HClSingle oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Healthy male and female subjects 18 to 55 years of age (inclusive).
Body mass within 10% of the ideal mass in relation to height and age, according to the Body Mass Index (BMI).
Body mass not less than 60 kg.
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the "normal ranges" for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study).
Normal electrocardiogram (ECG) and vital signs, or abnormalities which the investigator did not consider a disqualification for participation in the study.

Key exclusion criteria (21 listed)

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 contraceptive agents by females were 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tramadol HClSingle oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet or Tramadol HCl 200 mg Uncoated Tablets based on randomization schedule.	Drug	Tramadol HCl 200 mg Film-coated Tablets, Tramadol HCl 200 mg Uncoated Tablets

Primary outcome

AUC(0-t)
Time frame: 48 hours
Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.
AUC(0-Inf)
Time frame: 48 hours
Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.
Cmax
Time frame: 48 hours
Maximum plasma concentration

2 secondary outcomes

Tmax
Time frame: 48 hours
t1/2
Time frame: 48 hours

Results and safety

Results posted to the registry on 8 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tramadol HCl 200 mg Film-coated Tablets	13	12
Tramadol HCl 200 mg Uncoated Tablets	13	12

Primary outcome: AUC(0-t)

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Tramadol HCl 200 mg Film-coated Tablets n = 12	Tramadol HCl 200 mg Uncoated Tablets n = 12
Value	5181 (1338)	5010 (1176)

Primary outcome: AUC(0-Inf)

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Tramadol HCl 200 mg Film-coated Tablets n = 12	Tramadol HCl 200 mg Uncoated Tablets n = 12
Value	5328 (1421)	5175 (1241)

Primary outcome: Cmax

Time frame: 48 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	Tramadol HCl 200 mg Film-coated Tablets n = 12	Tramadol HCl 200 mg Uncoated Tablets n = 12
Value	218 (49)	209 (45)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tramadol HCl 200 mg Film-coated Tablets	0 of 25 (0%)	9 of 25 (36%)	Not reported
Tramadol HCl 200 mg Uncoated Tablets	0 of 25 (0%)	10 of 25 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Approved labellingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tramadol HCl in people with Healthy, run by Labopharm Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-t) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00834366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2012.