NCT05925686已完成1 期
Tramadol Administered Orally to Healthy Subjects for the Improvement of Its Detection in Biological Matrices in the Context of Anti-Doping Control
Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Urine concentration on Tramadol.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 and ≤ 55 years.
- •Weight ≥ 50 kg and ≤ 100 kg.
- •Body mass index (BMI) ≥ 18 and ≤
- •Negative serum pregnancy test (women only).
- •Signed informed consent prior to any study-mandated procedure.
排除标准
- •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.
研究组 & 干预措施
Tramadol.
Experimental
干预措施: Tramadol. (Drug)
结局指标
主要结局
Urine concentration on Tramadol.
时间窗: From baseline to 8 hours.
次要结局
- Plasma and dried blood spots (DBS) concentration on Tramadol.(From baseline to 12 hours.)
研究者
研究点 (1)
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