Clinical trial on the effects of the tramadol and paracetamol on physical, cognitive and brain performance during cycling

Daniel Sanabria0 个研究点目标入组 30 人开始时间: 2018年6月21日最近更新: 2019年6月30日

试验速览

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•To ensure the high-fit quality profile of the participants, male cyclists and triathletes with a above average of 90 percentile, according to normative values proposed by the American College of Sports Medicine, (16) will be recruited. Age will range from 18 to 40 years. -Signature of prior consent before any activity related to the study, including the necessary evaluations for the selection.
•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 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Any selected subject that meets at least one of the following exclusion criteria may not be included in the study:
•- Allergy to tramadol or any of its excipients
•- Allergy to paracetamol or any of its excipients
•- Presence of any heart disease symptom
•- Metabolic disorder such as obesity (BMI> 30) or diabetes
•- Chronic obstructive pulmonary disease (COPD)
•- Epilepsy or risk of seizures, such as withdrawal syndrome
•- Active treatment with ß-blockers
•- Subjects under treatment with MAO inhibitors or who have received them during the last 14 days
•- Consumption of alcohol, tobacco or any other drug of abuse that could incapacitate him to participate in the study.
•- Diagnosis of any other pathology that, in the opinion of the investigator, may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study.

发起方

Daniel Sanabria