PER-021-17Not yet recruiting未知
A PHASE I OPEN-LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A4+
SABELL PERU SAC,0 sites0 target enrollmentStarted: November 27, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Adult volunteers considered to be healthy according to medical and laboratory tests to be performed 10 days before the study start.
- •Volunteers signing the informed consent form to take part in the clinical trial.
- •Volunteers agreeing to follow recommendations on their life style by the clinical trial evaluating team for 3 months.
- •Volunteers accepting to use a contraceptive method (which does not interfere with the research study), as recommended by the principal investigator.
Exclusion Criteria
- •Adult volunteers considered to be healthy according to medical and laboratory tests to be performed 10 days before the study start. • Volunteers signing the informed consent form to take part in the clinical trial. • Volunteers agreeing to follow recommendations on their life style by the clinical trial evaluating team for 3 months. • Volunteers accepting to use a contraceptive method (which does not interfere with the research study), as recommended by the principal investigator. • Volunteers with any known chronic disease or diagnosed during the evaluation process or who have symptoms of an acute disease. • Pregnant, postpartum or breastfeeding women. • Childbearing women who wish to become pregnant within 3 months after the clinical trial start. • Volunteers taking any type of drug or vitamin supplement. • Subjects who have participated in other study within the last 30 days prior this clinical trial. • Subjects with legal or pending medical lawsuit. • Subjects with any inflammatory disease that may potentially increase C-reactive protein. • Subjects with any mental disorder which disables their comprehension. • Subjects with kidney stones or prone to develop kidney stones. • Subjects who have used depot hormonal contraceptives. • Subjects with history of addictions (e.g. alcohol, tobacco, illegal drugs, medications, compulsive gambling, etc.) which may interfere with the clinical trial or may not allow a correct monitoring.
Investigators
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