Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tramadol.
|
Drug: Tramadol.
Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers.
|
Outcome Measures
Primary Outcome Measures
- Urine concentration on Tramadol. [From baseline to 8 hours.]
Secondary Outcome Measures
- Plasma and dried blood spots (DBS) concentration on Tramadol. [From baseline to 12 hours.]
Other Outcome Measures
- Adverse effects. [From baseline to 24 hours.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 and ≤ 55 years.
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Weight ≥ 50 kg and ≤ 100 kg.
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Body mass index (BMI) ≥ 18 and ≤ 30.
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Negative serum pregnancy test (women only).
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Signed informed consent prior to any study-mandated procedure.
Exclusion Criteria:
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Smoker of more than 5 cigarettes per day in the last 3 months prior to participate in the study.
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History of psychiatric disorders, alcoholism or drug abuse.
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Positive urine pregnancy test.
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No highly effective anticonception measures during the trial.
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Breastfeeding.
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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.
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Major Surgery last 6 months.
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Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
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Subjects with a clinically significant disease within one month prior to study drug administration.
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Any clinically relevant findings in physical examination, vital signs, 12-lead ECG and safety laboratory parameters.
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Positive hepatitis or HIV test.
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Known hypersensitivity to any drug or drug excipients.
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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.
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Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within 2 weeks prior to study drug administration.
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Intake of more than 5 units per day of beverages containing xanthine (coffee, tea or cola drinks).
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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.
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History of inadequate venous access and/or experience of difficulty donating blood.
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Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
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Subject included in a clinical study within 3 months prior to study drug administration.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IMIM (Institut Hospital del Mar d'Investigacions Mèdiques) | Barcelona | Spain | 08003 |
Sponsors and Collaborators
- Parc de Salut Mar
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMIMFCTL/TRAM/1