DRKS00010707尚未招募未知

Sensory Supply Areas of Upper Limb Nerves: A Clinical Evaluation in Volunteers - neuro anatomy

适应症

试验速览

阶段: 未知
状态: 尚未招募
发起方: Medizinischen Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
入组人数: 20

暂无简介。

•Healthy male volunteers
•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
•18-55 years old inclusive
•Clearly detectable nerves in ultrasound evaluation (radial, median and ulnar nerves), 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

•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 one of the investigated nerves are 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
•Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal
•History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005)
•Abnormal or special diet (e.g. vegetarian diet)
•Other objections to study participation in the opinion of the investigator

发起方