PainPhase 1NCT00911742
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
A Phase 1 study testing Tramadol Contramid OAD and Zytram in people with Pain, run by Labopharm Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Tramadol Contramid OAD and Zytram
- 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 2004to Mar 2004
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
About this study
Official title: Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg 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.
- Conditions
- Pain
- Being tested
- Tramadol Contramid OAD, Zytram
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Contramid OADDrug
1 Tramadol Contramid OAD 200 mg tablet as a single dose
ZytramDrug
1 Zytram 200 mg tablet as a single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 Tramadol Contramid Once A Day | Experimental | Not described Receives: Drug: Tramadol Contramid OAD |
| 2 Zytram (R) | Active comparator | Not described Receives: Drug: Zytram |
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 measured concentration.
h=hour
Measured: 48 hours
AUC (0-∞)
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
Measured: 48 hours
Cmax
Maximum plasma concentration
Measured: 48 hours
Secondary outcomes (2)
t1/2
Apparent terminal elimination half-life
Measured: 48 hours
Tmax
Time to maximum plasma concentration
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 posted2 Jun 2009 (estimated)
- Study startFeb 2004
- Primary completionMar 2004
- Study completionMar 2004
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 PainStudies 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911742
- Sponsor's protocol ID
- MDT1-012
- Status last verified
- Apr 2012
- First submitted
- 8 Apr 2009
- Last updated
- 27 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Hernandez-Lopez C, Martinez-Farnos L, Karhu D, Perez-Campos T, Rovira S, Encina G. Comparative bioavailability between two Tramadol once-daily oral formulations. Methods Find Exp Clin Pharmacol. 2006 Jul-Aug;28(6):373-8. doi: 10.1358/mf.2006.28.6.1007674.
PubMed 16894407
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
- Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg OAD Formulation Versus Zytram® 200 mg
- ClinicalTrials.gov ID
- NCT00911742
- Acronym / sponsor ID
- MDT1-012
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 2 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Tramadol Contramid Once A Day | Experimental | Drug: Tramadol Contramid OAD |
| 2 Zytram (R) | Active comparator | Drug: Zytram |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 Contramid OAD1 Tramadol Contramid OAD 200 mg tablet as a single dose | Drug | 1 Tramadol Contramid Once A Day |
| Zytram1 Zytram 200 mg tablet as a single dose | Drug | 2 Zytram (R) |
Primary outcome
AUC(0-t)
Time frame: 48 hours
Area under the plasma concentration versus time curve to the last measured concentration. h=hour
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
Cmax
Time frame: 48 hours
Maximum plasma concentration
2 secondary outcomes
t1/2
Time frame: 48 hours
Tmax
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 16894407Hernandez-Lopez C, Martinez-Farnos L, Karhu D, Perez-Campos T, Rovira S, Encina G. Comparative bioavailability between two Tramadol once-daily oral formulations. Methods Find Exp Clin Pharmacol. 2006 Jul-Aug;28(6):373-8. doi: 10.1358/mf.2006.28.6.1007674.
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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 Contramid OAD and Zytram in people with Pain, 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 10 inclusion and 14 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 NCT00911742, 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.