NL-OMON37682已完成不适用
Pharmacokinetics in Plasma and Saliva of a Single Dose Caffeine in Healthy Volunteers - Caffeine PK
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject must be 18-35 years of age (inclusive)
- •- Subject has a Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive) and body weight between 50 kg and 90 kg (inclusive);
- •- Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff;
- •- Subject is willing to comply with study restrictions.
排除标准
- •- Clinically relevant abnormal history of physical and mental health as determined by medical history taking and physical examinations obtained during the screening visit (as judged by the investigator);
- •- Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening (as judged by the investigator);
- •- Positive test for hepatitis B, C or HIV at screening;
- •- Positive urinary pregnancy test (females only) at screening;
- •- History of alcoholism or substance abuse within three years prior to screening;
- •- Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week;
- •- Positive urine drug screen at screening;
- •- Subject uses more than 5 units of xanthine-containing food products or drinks (including but not limited to coffee, tea, Red Bull, chocolate) daily;
- •- Subject is a smoker (> 5 cigarettes per day) or has used nicotine/nicotine-containing products within 3 months prior to screening;
- •- Subject is unable to refrain from the use of disallowed concomitant medication, dietary supplements or food products from one week prior to the first caffeine administration until the end of the last occasion;
- •- Subject is unable to refrain from food and drinks containing a xanthine (e.g. chocolate, cola, energy drinks, coffee or tea) from from 3 days prior to until the end of the study days;
- •- Participation in an investigational drug study within 90 days prior to the first dose and/or participation in more than 4 clinical trials in the last year;
- •- Donation or loss of blood (> 500 mL) within 3 months prior to screening.
研究者
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