Safety of Orally Administered Neutral pH Super Oxidation Electrolyzed Solutio

Phase 1

• Conditions: Healthy; Healthy Volunteers

• Registration Number: RPCEC00000427
• Lead Sponsor: Esteripharma Laboratory

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-21
• Study Completion: 2024-01-31
• Results First Posted: 2024-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age between 18 and 45 years. 2. That they do not present signs or symptoms of an acute illness. 3 In case of suffering from any chronic degenerative disease, which is controlled and without presenting complications. 4. Sign informed written consent voluntarily.

Exclusion Criteria

1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Previously diagnosed heart disease (ischemic). 4. Decompensated systemic chronic disease. 5. Creatinine 1.25 times higher than the normal value or creatinine clearance less than 50 milliliters/minute (Cockfrot and Gault method). 6. Blood hemoglobin less than 10g/Dl. 7. Increase in the last month of diastolic blood pressure of 110 mmHg or more and/or appearance of hematuria or proteinuria greater than 300 milligrams/day. 8. Intestinal pseudo-obstruction. Defined as abdominal pain, with air-fluid levels on AP abdominal radiographs and standing lateral. 9. Pregnant and lactating women. 10. Drug addiction (illegal drugs). 11. Known liver disease with doubling of liver function tests (Aspartate amino transferase (AST), Alanine amino transferase (ALT), Alkaline phosphatase, Bilirubin). 12. Presence of Cancer. 13. Other pathologies at the discretion of the researcher.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events-AE (Present, Absent). AEs will be classified according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE). Measurement time: Daily until the 15th or until the AEs that arise are resolved.

Secondary Outcome Measures

Name	Time	Method
Change in blood serum laboratory test values (Na, K, Cl, prothrombin time, partial thromboplastin time, cholesterol, triglycerides, glucose, urea, creatinine, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, albumin, bilirubin, lactate dehydrogenase biometry), in whole blood (hematic biometry and erythrocyte sedimentation rate), in feces (coproparasitoscopic and stool analysis), and in urine (general urinalysis, protein, creatinine, and Na in a random urine sample). Measurement time for serum and whole blood analysis: Basal, 5 and 10 days. Measurement time for analysis in feces and urine: Basal and after 10 days.