NCT03868748

Safety Evaluation of β-arbutin in Healthy Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: SP Nutraceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objective and purpose of this Phase I study is to investigate the safety of synthetic beta-arbutin, administered to healthy human subjects for: i) 12 weeks, at a dose of 150 mg/day, and ii) 4 weeks, at a dose of 400mg/day. Safety will be determined by assessing adverse event rates between treatment groups and mean changes relative to baseline in serum biochemical, hematological and urinary markers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Beta-arbutin	Beta-arbutin capsules
OTHER	Placebo	Placebo capsules containing non-medicinal ingredients

Timeline

• Start date: 2019-10-23
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2019-03-11
• Last updated: 2022-05-27

Locations

2 sites across 1 country: Canada