A PHASE I OPEN-LABEL RANDOMIZED CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A4+

Not Applicable

• Conditions: -K73; K73

• Registration Number: PER-021-17
• Lead Sponsor: SABELL PERU SAC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-27
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified