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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05925686
• Other study ID #: IMIMFCTL/TRAM/1
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2023
• Est. completion date: October 17, 2023

Study information

• Verified date: March 2023
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 17, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Spain	IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects.		From baseline to 24 hours.
Primary	Urine concentration on Tramadol.		From baseline to 8 hours.
Secondary	Plasma and dried blood spots (DBS) concentration on Tramadol.		From baseline to 12 hours.