DRKS00017750已完成4 期
The Effectiveness of Generic Local Anaesthetics in Comparison with the Original Drug: A Randomized, Triple-blinded and Crossover Study in Volunteers
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie0 个研究点目标入组 18 人开始时间: 2019年12月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •Healthy males
- •- Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator
- •- Signed written informed consent prior to inclusion in the study
- •- 18-60 years old inclusive
- •- Clearly detectable ulnar nerve at the non-dominant arm in ultrasound evaluation, according to the main investigators opinion
- •- BMI: 18 to 35 kg/m2
- •- Ability to understand the full nature and purpose of the study, including possible risks and side effects
- •- Ability to co-operate with the investigator and to comply with the requirements of the entire study
- •- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
排除标准
- •- Any clinically relevant abnormalities at ECG (12 leads)
- •- Any clinically relevant abnormal physical findings
- •- Any clinically relevant abnormal laboratory values indicative of physical illness
- •- Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug
- •- History of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
- •- If the ulnar nerve is not clearly visible in ultrasound
- •- Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study
- •- Any psychiatric illnesses
- •- Using other medications during 1 week before the start of IMP application including OTC
- •- Participation in another clinical study investigating another IMP within 1 month prior to screening
- •- History of alcohol or illicit substance abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2015)
- •- Other objections to study participation in the opinion of the investigator
研究者
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