se of tramadol in healthy volunteers.Effects on physical performance and sustained attention in cycling.

Phase 1

• Conditions: Sport doping; MedDRA version: 18.1Level: LLTClassification code 10076471Term: Drug dopingSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2015-005056-96-ES
• Lead Sponsor: Daniel Sanabria Lucena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Signed informed consent before any activity related with the study, including assessments required for the selection.

- Age between 18 and 35 years inclusive.

- If women would find no confirmation pregnant or breastfeeding and commitment to use adequate contraception as hormonal contraception, intrauterine device or barrier methods (vaginal condom or diaphragm) along the entire study period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Allergy to tramadol or any of the excipients
- Any symptoms of heart disease
- Metabolic disorder such as obesity (BMI> 30) or diabetes
- Chronic obstructive pulmonary disease (COPD)
- Epilepsy or seizure risk as withdrawal
- Active treatment with beta-blockers
- Patients treated with MAO inhibitors or that they have received
Over the past 14 days
- Consumption of alcohol, snuff or other drugs of abuse that could
incapacitate to participate in the study.
- Diagnosis of any other condition that the investigator's opinion, may
increase the risk of the subject or reduce the chances of obtaining data
satisfactory to achieve the objectives of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified