Status:
SUSPENDED
Safety and Efficacy of EZ-Ject Injector a Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
Lead Sponsor:
Sindolor
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Subcutaneous injections are a widely used method for drug delivery. One of its major drawbacks is the pain inflicted during the process. Sindolor has developed the chemical-free EZ-Ject Injector devic...
Eligibility Criteria
Inclusion
- Healthy Caucasian males and females between 18 and 50 years of age.
- Colour of skin that will enable to clearly observe dermal effects.
- Non-pregnant, non-lactating female subjects whose urine screening pregnancy test is negative.
- Subjects must be available to complete the study.
- Subjects must satisfy a medical examiner about their fitness to participate in the study.
- Subjects must provide written informed consent to participate in the study.
Exclusion
- Persons with a large amount of hair on the injection sites
- Presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions that could interfere with the observation of the injection sites.
- History of skin allergy or hypersensitivity
- History of severe skin infection in the past 1 year.
- History of easy bruising.
- Current or previous history of neurological disorders (particularly neuropathies), low back pain with neurological involvement.
- Any psychological condition that could influence the conduct of the study or interpretation of results.
- A history of drug or alcohol abuse
- Use of alcohol or medications within 48 hours prior to and during study participation
- Any condition, which in the opinion of the Principal Investigator or the study physician would place the subject at risk or influence the conduct of the study or interpretation of results.
- Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Pregnancy
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00684333
Start Date
June 1 2009
End Date
February 1 2010
Last Update
January 14 2009
Active Locations (1)
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1
Ichilov Medical center
Tel Aviv, Israel