Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls

Study Overview
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Brief Summary
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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.

Official Title
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Tramadol Administered Orally to Healthy Subjects for the Improvement of Its Detection in Biological Matrices in the Context of Anti-Doping Control

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tramadol.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tramadol.<br> | Drug: Tramadol.<br>* Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine concentration on Tramadol. |  | From baseline to 8 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and dried blood spots (DBS) concentration on Tramadol. |  | From baseline to 12 hours. |