HealthyPhase 1NCT05925686
Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls
A Phase 1 study testing Tramadol. in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers will be administered with the objective to evaluate urine and blood concentrations in healthy volunteers. 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.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 17 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age ≥ 18 and ≤ 55 years.
- Weight ≥ 50 kg and ≤ 100 kg.
- Body mass index (BMI) ≥ 18 and ≤ 30.
- Negative serum pregnancy test (women only).
- Signed informed consent prior to any study-mandated procedure.
Who cannot join
- Smoker of more than 5 cigarettes per day in the last 3 months prior to participate in the study.
- History of psychiatric disorders, alcoholism or drug abuse.
- Positive urine pregnancy test.
- No highly effective anticonception measures during the trial.
- Breastfeeding.
- Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
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- Any clinically relevant disease or condition (cardiovascular, renal, hepatic, endocrine, hematology, neurology o other acute or chronic diseases) that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
- Major Surgery last 6 months.
- Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
- Subjects with a clinically significant disease within one month prior to study drug administration.
- Any clinically relevant findings in physical examination, vital signs, 12-lead ECG and safety laboratory parameters.
- Positive hepatitis or HIV test.
- Known hypersensitivity to any drug or drug excipients.
- Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study.
- Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within 2 weeks prior to study drug administration.
- Intake of more than 5 units per day of beverages containing xanthine (coffee, tea or cola drinks).
- Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
- History of inadequate venous access and/or experience of difficulty donating blood.
- Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
- Subject included in a clinical study within 3 months prior to study drug administration.
Trial locations and contacts
1 site in 1 country.
Spain1 site
IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)
Barcelona, 08003
About this study
Official title: Tramadol Administered Orally to Healthy Subjects for the Improvement of Its Detection in Biological Matrices in the Context of Anti-Doping Control
Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers will be administered with the objective to evaluate urine and blood concentrations in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Tramadol.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol.Drug
Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol. | Experimental | Not described Receives: Drug: Tramadol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration on Tramadol.
Measured: From baseline to 8 hours.
Secondary outcomes (1)
Plasma and dried blood spots (DBS) concentration on Tramadol.
Measured: From baseline to 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jun 2023
- Primary completion11 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925686
- Sponsor's protocol ID
- IMIMFCTL/TRAM/1
- Status last verified
- Mar 2023
- First submitted
- 15 May 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tramadol Administered Orally to Healthy Subjects for the Improvement of Its Detection in Biological Matrices in the Context of Anti-Doping Control
- ClinicalTrials.gov ID
- NCT05925686
- Acronym / sponsor ID
- IMIMFCTL/TRAM/1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers will be administered with the objective to evaluate urine and blood concentrations in healthy volunteers.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tramadol. | Experimental | Drug: Tramadol. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ≥ 18 and ≤ 55 years.
- Weight ≥ 50 kg and ≤ 100 kg.
- Body mass index (BMI) ≥ 18 and ≤ 30.
- Negative serum pregnancy test (women only).
- Signed informed consent prior to any study-mandated procedure.
Key exclusion criteria (20 listed)
- Smoker of more than 5 cigarettes per day in the last 3 months prior to participate in the study.
- History of psychiatric disorders, alcoholism or drug abuse.
- Positive urine pregnancy test.
- No highly effective anticonception measures during the trial.
- Breastfeeding.
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.Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers. | Drug | Tramadol. |
Primary outcome
Urine concentration on Tramadol.
Time frame: From baseline to 8 hours.
1 secondary outcome
Plasma and dried blood spots (DBS) concentration on Tramadol.
Time frame: From baseline to 12 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tramadol. in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.
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 5 inclusion and 20 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 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urine concentration on Tramadol. (time frame: From baseline to 8 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2023.