NL-OMON50771
Completed
Not Applicable
A phase I, open label clinical trial in healthy volunteers, to assess and characterize the effect of FIRTECH infrared patch on tissue perfusion, oxygenation and local microcirculation. - FIRTECH local blood microcirculation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sanofi Aventis Groupe
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent prior to any study\-mandated procedure
- •2\. Healthy male or female subjects, 18 to 55 years of age, inclusive.
- •3\. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and
- •with a minimum weight of 50 kg.
- •4\. Has the ability to communicate well with the Investigator in the Dutch
- •language and willing to comply with the study restrictions.
Exclusion Criteria
- •1\. Evidence of any active or chronic disease or condition that could interfere
- •with, or for which the treatment of might interfere with, the conduct of the
- •study, or that would pose an unacceptable risk to the subject in the opinion of
- •the investigator (following a detailed medical history, physical examination,
- •vital signs (systolic and diastolic blood pressure, pulse rate, body
- •temperature) and12\-lead electrocardiogram (ECG)). Minor deviations from the
- •normal range may be accepted, if judged by the Investigator to have no clinical
- •2\. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including hepatic and renal panels, complete blood
- •count, chemistry panel and urinalysis). In the case of uncertain or
Outcomes
Primary Outcomes
Not specified
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