NCT03868748已完成1 期
Safety Evaluation of β-arbutin in Healthy Human Subjects
SP Nutraceuticals Inc.4 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年10月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Incidence and severity of Adverse Events (AE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, aged 18-65 years
- •includes non-pregnant, non-breastfeeding women on adequate birth control
- •acceptable effective contraceptive methods for participants with child-bearing potential include: barrier methods (condoms), total abstinence, hormonal birth control methods (oral, injectable, transdermal, or intra-vaginal), intrauterine devices, and confirmed successful vasectomy of partner;
- •Body Mass Index (BMI) of 18.5-35 kg/m2;
- •Generally healthy (absence of active clinical disease as determined by serum biochemical, hematological, and urinary parameter tests as well as detailed medical history and blood pressure measurements) as assessed by the PI/QI;
- •Males and females of childbearing potential willing to use appropriate effective contraception for the duration of the study;
- •Agrees to maintain current diet and exercise routine during the study;
- •Ability to provide written informed consent; and
- •Willing to comply with all study requirements and provide urine and blood specimens over the 12-week study period..
排除标准
- •Pregnant or breastfeeding women;
- •History of renal dysfunction;
- •History of macular degeneration as assessed by the PI/QI;
- •History of liver disease as assessed by the PI/QI;
- •Type I or Type II diabetes;
- •Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the PI/QI History of renal dysfunction, as assessed by the PI/QI;
- •Cancer being actively treated with systemic therapy (i.e. chemotherapy, immune therapy);
- •Self-reported HIV-, Hepatitis B-, and/or C-positive diagnosis;
- •High alcohol intake (average of > 2 standard drinks per day);
- •Heavy smokers (average of >10 cigarettes per day);
- •Use of cannabinoid products within 30 days of enrollment;
- •Any history of major surgery (i.e. inter-abdominal, inter-thoracic, inter-cranial) within the last six months, or surgery planned during the course of the study;
- •Known hypersensitivity to arbutin;
- •Allergy to all ingredients (including non-medicinal ingredients) in investigational products and placebo product
- •Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation; and
- •Clinically significant abnormal laboratory results at screening as assessed by the PI/QI
结局指标
主要结局
Incidence and severity of Adverse Events (AE)
时间窗: During treatment period (Day 1 to Day 84)
Number of treatment emergent adverse events according to CTCAE v5.0.
次要结局
- Participant compliance to treatment(During treatment period (day 7, day 28, day 56, day 84))
- Biochemistry(At screening and during treatment period (day 7, day 28, day 56, day 84))
- Urinalysis (Microscopy)(At screening and during treatment period (day 7, day 28, day 56, day 84))
- Hematology(At screening and during treatment period (day 7, day 28, day 56, day 84))
- Urinalysis (Routine)(At screening and during treatment period (day 7, day 28, day 56, day 84))
- Urine culture(At screening and during treatment period (day 7, day 28, day 56, day 84))
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With AsthmaAsthmaNCT00986037AbbVie47
已完成
不适用
Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABASleep DisturbanceNCT04857021Amorepacific Corporation60
已完成
1 期
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected SubjectsHCV InfectionNCT00696904AbbVie133
已完成
不适用
Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B in Perimenopausal Women.Perimenopause, Climacteric SyndromeNCT03897738I.M. Sechenov First Moscow State Medical University106
招募中
不适用
Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiCholDyslipidemiasNCT06340308University of Pavia36