Study to Assess Safety and Efficacy of Nephrosolid Tbs to Stimulate Urinary Output in Non-patient Volunteers

Urine Specimen Collection Clinical Trial

Official title: Multizentrische, Offene Studie Zur Beurteilung Der Verträglichkeit Und Wirksamkeit Von Nephrosolid Tabletten Zur Anregung Der Harnausscheidung Bei Probanden/Non-patient Volunteers

Status Completed

Clinical Trial Summary

Fluid intake and urinary output are measured with /without intake of Nephrosolid tablets in acute ( 1 day application ) and chronic ( 28 days application) therapy.

Clinical Trial Description

To evaluate safety and efficacy of Nephrosolid tbs in the stimulation of urinary output in healthy volunteers, all participants in this open-label study will be asked to record their fluid intake and output on day 0 (without study medication), on day 1 (with 3 x 2 tablets study medication, to be taken 1/2 hour before meals) and on day 28 (with 2 x 1 tablets study medication, morning and noon half an hour before meals) and to take 2 x 1 tablet of Nephrosolid on days 2-28. Subjects will complete a diary during the study to record the tablets taken, amount of fluid consumed, weight, physical activity, and urinary measurement. Safety labs (hematology, clinical chemistry) will be performed at each study visit on days -1 and 29. ;

Related Conditions & MeSH terms

• Urine Specimen Collection

• NCT number: NCT04338477
• Study type: Interventional
• Source: Bioforce AG
• Status: Completed
• Phase: Phase 3
• Start date: February 12, 2018
• Completion date: January 31, 2019