NL-OMON40468招募中不适用
A proof of concept study on the effect of tianeptine on opioid-induced respiratory depression - STORD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
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
- •Age of 18 to 35 years (inclusive);;Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight between 50 kg and 100 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 and/or prior to the administration of the initial dose of the study drug (as judged by the investigator); ;A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening; ;History of alcoholism or substance abuse within three years prior to screening; ;Positive pregnancy test; ;Subjects using more than 20 units of alcohol per week;
- •Use of medication during the study period;
- •If sexually active, the subject is not using oral contraceptives, or surgically sterilized; ;Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-*prescription drugs or food; ;Participation in an investigational drug trial in the 2 months prior to administration of the initial dose of study drug or more than 5 times per year; ;Any other condition that in the opinion of the investigator would
- •complicate or compromise the study, or the wellbeing of the subject.
研究者
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