DRKS00017750
Completed
Phase 4
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 sites18 target enrollmentDecember 3, 2019
Conditionserve block
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- erve block
- Sponsor
- Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
- Enrollment
- 18
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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