Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls (NCT05925686) | Clinical Trial Compass
CompletedPhase 1
Tramadol to Improve Its Detection in Biological Matrices in Anti-doping Controls
Spain25 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dru…