HealthyPhase 1NCT00834808
A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers
A Phase 1 study testing Tramadol HCl in people with Healthy, run by Labopharm Inc..
Trial summary
The purposes of this study were: To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite, the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of tramadol as the Labopharm extended-release formulation prepared with Contramid. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy 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
- 27 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Dec 2002
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
- Males aged from 18 to 45 years inclusively and with Body Mass Index (BMI) between 18 and 30 kg/m2 inclusively.
- Clinical laboratory values within 10% above or below the laboratory's stated normal range; if not within this range, the clinical investigator will decide if they were not clinically significant and recorded this fact on the Case Report Form (CRF).
- Healthy according to the physical examination and laboratory results.
- Normal cardiovascular function according to a 12-lead electrocardiogram (ECG).
- Non-smoker or subjects smoking no more than 5 cigarettes per day (or equivalent) and able to abstain from smoking during inpatient phases of the study.
- Subjects covered by Social Security in compliance with the recommendations of French Law relating to biomedical research.
- Subjects with normal dietary requirements (neither vegetarian, nor on a diet).
Who cannot join
- History of hypersensitivity to tramadol or any other compounds.
- Presence or significant history of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Presence or significant history of cardiovascular, pulmonary, haematological, neoplasic, neurological, psychiatric, endocrine, immunological or dermatological disease.
- Presence or significant history of glaucoma.
- Supine pulse rate lower than 45 beats per minute (bpm) after 5 minutes at rest or higher than 100 bpm.
- History of hypotensive episodes or a standing systolic blood pressure reading of <100 mmHg or a diastolic reading of <45 mmHg, measured on the screening day.
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- History of hypertensive episodes or a supine systolic blood pressure reading of >145 mmHg or a diastolic reading of >95 mmHg, measured on the screening day.
- Presence of atrioventricular (AV) block assessed during pre-study evaluation or during the study. The lower limit considered for a first degree AV block was be a PR interval of 200 millisecond (msec).
- Maintenance therapy with any drug, or history of drug dependency, alcohol abuse (>3 units of alcohol per day), or serious psychological disease.
- Subjects consuming large quantities of drinks containing xanthine bases (coffee, tea, chocolate or cola; more than 6 cups or glasses per day).
- Any clinically significant illness in the previous 21 days before day 1 of this study.
- Subjects who had undergone general anesthesia within 3 months prior to the present study.
- Use of drugs known to affect liver enzymes (eg, inducers or inhibitors of Cytochrome P450) in the previous 30 days before day 1 of this study (eg, all barbiturates, corticosteroids, di \& methyl-phenylhydantoin).
- Use of any medication (including OTC preparations) in the previous 14 days before day 1 of this study.
- Donation of 350 mL (or more) of blood in the previous 3 months or participation in another clinical trial in the previous 3 months before day 1 of this study.
- Subjects undergoing dental care.
- Positive urine drug screening.
- Positive results to human immunodeficiency virus (HIV) 1 \& 2 or hepatitis B surface antigen (HBsAg) or anti-HCV (hepatitis C virus) tests.
- History of fainting upon blood sampling.
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participate in the study or to limit the ability to comply with the protocol requirements.
- Subjects unable to abstain from intensive muscular effort or sport competitions during the week prior to the study and throughout the study itself.
- Subjects who had forfeited his freedom by administrative or legal award or who were under guardianship.
- Subjects who received the ceiling amount of 25,000 francs within the last 12 months or who reached this ceiling with the payment of this allowance for this study.
About this study
The purposes of this study were:
- To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite, the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of tramadol as the Labopharm extended-release formulation prepared with Contramid.
- To assess the dose linearity of tramadol and its principal metabolite, the O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of the Labopharm extended-release formulation prepared with Contramid under fasting conditions in young healthy volunteers.
- 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
One single oral administration of Tramadol HCl 100 mg, 200 mg or 300 mg as per randomization schedule.
| Study group | Role | What they receive |
|---|---|---|
| 1: Tramadol HCl 100mg | Experimental | Not described Receives: Drug: Tramadol HCl |
| 2: Tramadol HCl 200mg | Experimental | Not described Receives: Drug: Tramadol HCl |
| 3: Tramadol HCl 300mg | Experimental | Not described 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 the plasma concentration versus time curve to the last measurable concentration.
h = hours
Measured: 48 hours
AUC(0-inf)
Area under the plasma concentration versus time curve extrapolated to infinity. h = hours
Measured: 48 hours
Cmax
Maximum plasma concentration.
Measured: 48 hours
Secondary outcomes (2)
Tmax
Time to maximum plasma 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.
- First posted3 Feb 2009 (estimated)
- Study startNov 2002
- Primary completionDec 2002
- Study completionDec 2002
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834808
- Sponsor's protocol ID
- MDT1-011
- Status last verified
- Apr 2012
- First submitted
- 30 Jan 2009
- Last updated
- 27 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Karhu D, El-Jammal A, Dupain T, Gaulin D, Bouchard S. Pharmacokinetics and dose proportionality of three Tramadol Contramid OAD tablet strengths. Biopharm Drug Dispos. 2007 Sep;28(6):323-30. doi: 10.1002/bdd.561.
PubMed 17575561
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT00834808
- Acronym / sponsor ID
- MDT1-011
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 2 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study were:
- To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite, the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of tramadol as the Labopharm extended-release formulation prepared with Contramid.
- To assess the dose linearity of tramadol and its principal metabolite, the O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of the Labopharm extended-release formulation prepared with Contramid under fasting conditions in young healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1: Tramadol HCl 100mg | Experimental | Drug: Tramadol HCl |
| 2: Tramadol HCl 200mg | Experimental | Drug: Tramadol HCl |
| 3: Tramadol HCl 300mg | Experimental | Drug: Tramadol HCl |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
- Males aged from 18 to 45 years inclusively and with Body Mass Index (BMI) between 18 and 30 kg/m2 inclusively.
- Clinical laboratory values within 10% above or below the laboratory's stated normal range; if not within this range, the clinical investigator will decide if they were not clinically significant and recorded this fact on the Case Report Form (CRF).
- Healthy according to the physical examination and laboratory results.
- Normal cardiovascular function according to a 12-lead electrocardiogram (ECG).
Key exclusion criteria (23 listed)
- History of hypersensitivity to tramadol or any other compounds.
- Presence or significant history of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Presence or significant history of cardiovascular, pulmonary, haematological, neoplasic, neurological, psychiatric, endocrine, immunological or dermatological disease.
- Presence or significant history of glaucoma.
- Supine pulse rate lower than 45 beats per minute (bpm) after 5 minutes at rest or higher than 100 bpm.
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 HClOne single oral administration of Tramadol HCl 100 mg, 200 mg or 300 mg as per randomization schedule. | Drug | 1: Tramadol HCl 100mg, 2: Tramadol HCl 200mg, 3: Tramadol HCl 300mg |
Primary outcome
AUC(0-t)
Time frame: 48 hours
Area under the plasma concentration versus time curve to the last measurable concentration. h = hours
AUC(0-inf)
Time frame: 48 hours
Area under the plasma concentration versus time curve extrapolated to infinity. h = hours
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17575561Karhu D, El-Jammal A, Dupain T, Gaulin D, Bouchard S. Pharmacokinetics and dose proportionality of three Tramadol Contramid OAD tablet strengths. Biopharm Drug Dispos. 2007 Sep;28(6):323-30. doi: 10.1002/bdd.561.
- 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 8 inclusion and 23 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 27 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 2 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 NCT00834808, which also lists 1 linked publication.
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 27 Apr 2012.