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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tramadol.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ana Aldea Perona, PhD; Phone Number: +34933160484; Email: aaldea@imim.es
• Study Contact Backup: Name: Rafael De la Torre Fornell, PhD; Phone Number: +34933160484; Email: rtorre@imim.es

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Adverse effects.	From baseline to 24 hours.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: IMIMFCTL/TRAM/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No