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Safety Evaluation of β-arbutin in Healthy Human Subjects

NCT03868748 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-05-27

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of synthetic beta-arbutin, a dietary supplement that aids in the prevention and treatment of calcium oxalate kidney stones, when administered to healthy human subjects.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

Beta-arbutin

Beta-arbutin capsules

OTHER

Placebo

Placebo capsules containing non-medicinal ingredients

Sponsors & Collaborators

  • Canadian Glycomics Network (GlycoNet)

    collaborator UNKNOWN

  • SP Nutraceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Hassan Razvi, MD, FRCSC · Chair/Chief, Division of Urology

  • David Crowley, MD · KGK Science site qualified investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868748 on ClinicalTrials.gov