Pharmacodynamics of Liposomal Bupivacaine for Peripheral Nerve Blockade: A Randomized, Triple-blinded, Cross Over Study in Volunteers

Medical University Vienna0 个研究点目标入组 27 人开始时间: 2023年1月20日最近更新: 2024年7月8日

适应症

试验速览

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•Healthy males and females
•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 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•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
•Pregnancy and breastfeeding
•Any psychiatric illnesses
•Any anticoagulatory or pain-therapy-related drugs (e.g. NSAIDs, opioids) from one week before until the end of the study
•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 4 weeks prior to this study
•History of drug or alcohol abuse (more than 2 glasses of either a small beer, 1/8 L wine or 2 cL spirits per day)
•Other objections to study participation in the opinion of the investigator

发起方

Medical University Vienna