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

NCT05925686 | Completed Phase 1

• 1 other identifier: IMIMFCTL/TRAM/1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Urine concentration on Tramadol.

  From baseline to 8 hours.

Secondary Outcomes (1)

• Plasma and dried blood spots (DBS) concentration on Tramadol.

  From baseline to 12 hours.

Other Outcomes (1)

• Adverse effects.

  From baseline to 24 hours.

Study Arms (1)

Tramadol.

EXPERIMENTAL

Drug: Tramadol.

Interventions

Tramadol. DRUG

Orally single dose administration of Tramadol 75 mg for ultra-rapid metabolizers and 100 mg for extensive and poor metabolizers.

Tramadol.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)

Barcelona, 08003, Spain

Location

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 29, 2023
• Study Start: June 1, 2023
• Primary Completion: October 11, 2023
• Study Completion: October 17, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-03

Locations

ES (1)