The Effectiveness of Generic Local Anaesthetics in Comparison with the Original Drug: A Randomized, Triple-blinded and Crossover Study in Volunteers
- Conditions
- erve block
- Registration Number
- DRKS00017750
- Lead Sponsor
- Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 18
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: <br>Duration of sensory nerve blockade
- Secondary Outcome Measures
Name Time Method Secondary Objective: <br>- Duration of motor blockade<br>- Onset time of sensory nerve blockade<br>- Onset time of motor blockade<br>- pH Value of the LA<br>- PK Parameter (Cmax, tmax, t1/2, AUC, CL, Vd)<br>