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

• Status: Completed
• Trial end date: 2023-10-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Parc de Salut Mar
• Treatments: Tramadol

Criteria

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.