Healthy SubjectsPhase 1NCT00834288
A Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
A Phase 1 study testing Tramadol HCl in people with Healthy Subjects and Pharmacokinetics, run by Labopharm Inc..
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Pharmacokinetics, Bioavailability
- 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
- Jun 2003to Aug 2003
- 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, 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.
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- 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.
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 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.
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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 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.
About this study
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.
- Conditions
- Healthy Subjects, Pharmacokinetics, Bioavailability
- Being tested
- Tramadol HCl
- Keywords
- Healthy subjects, Pharmacokinetics, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HClDrug
1x200 mg Tramadol HCl OAD tablet daily
Tramadol HClDrug
1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly
| Study group | Role | What they receive |
|---|---|---|
| 1: 1x200 mg Tramadol HCl OAD tablet daily | Experimental | Not described Receives: Drug: Tramadol HCl |
| 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly | Active comparator | Not described Receives: Drug: Tramadol HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)
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.
Measured: 24 hours (day 5)
Secondary outcomes (7)
Maximum Plasma Concentration at Steady State(Cmax,ss)
Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.
Measured: 24 hours (day 5)
Minimum Plasma Concentration at Steady State(Cmin,ss)
Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.
Measured: 24 hours (day 5)
Time to Peak Exposure (Tmax)
Time to peak exposure over 24 hours (24h) at steady state on day 5.
Measured: 24 hours (day 5)
Percentage Peak-trough Fluctuation (% PTF)
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).
Measured: 24 hours (day 5)
Percentage Swing
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.
Measured: 24 hours (day 5)
Half-value Duration (HVD)
Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.
Measured: 24 hours (day 5)
Plateau Time (T75%Cmax)
Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.
Measured: 24 hours (day 5)
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 startJun 2003
- Primary completionAug 2003
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 Healthy SubjectsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834288
- Sponsor's protocol ID
- MDT1-009
- Status last verified
- Apr 2012
- First submitted
- 30 Jan 2009
- Last updated
- 27 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Karhu D, Fradette C, Potgieter MA, Ferreira MM, Terblanche 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.
PubMed 20051587
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 Study to Compare the Bioavailability of Two Tramadol Hydrochloride Tablet Products (50 mg and 200 mg, Respectively) at Steady-state Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00834288
- Acronym / sponsor ID
- MDT1-009
- Conditions
- Healthy Subjects, Pharmacokinetics, Bioavailability
- Keywords
- Healthy subjects, Pharmacokinetics, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Aug 2003 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 19 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: 1x200 mg Tramadol HCl OAD tablet daily | Experimental | Drug: Tramadol HCl |
| 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly | Active comparator | Drug: Tramadol HCl |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
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 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.
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 HCl1x200 mg Tramadol HCl OAD tablet daily | Drug | 1: 1x200 mg Tramadol HCl OAD tablet daily |
| Tramadol HCl1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly | Drug | 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly |
Primary outcome
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.
7 secondary outcomes
Maximum Plasma Concentration at Steady State(Cmax,ss)
Time frame: 24 hours (day 5)
Minimum Plasma Concentration at Steady State(Cmin,ss)
Time frame: 24 hours (day 5)
Time to Peak Exposure (Tmax)
Time frame: 24 hours (day 5)
Percentage Peak-trough Fluctuation (% PTF)
Time frame: 24 hours (day 5)
Percentage Swing
Time frame: 24 hours (day 5)
Half-value Duration (HVD)
Time frame: 24 hours (day 5)
Plateau Time (T75%Cmax)
Time frame: 24 hours (day 5)
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 20051587Karhu D, Fradette C, Potgieter MA, Ferreira MM, Terblanche 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.
- 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 Subjects and Pharmacokinetics, 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 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 19 Oct 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?
Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss) (time frame: 24 hours (day 5)). 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 NCT00834288, 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.