Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Bioavailability of Alda-341 in salivary gland tissue using GCMS
研究概览
简要总结
The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement.
Salivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues.
详细描述
Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue.
Secondary Objective: To determine the bioavailability of Alda-341 in saliva and blood
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor
- •Ability to adhere to study visit schedule and other protocol requirements
- •Operable candidate base on the surgeon's note
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Nursing or pregnant
- •Diagnosis of kidney disease, history of renal disease with creatinine > 1.5 mg/dL, or currently on dialysis
- •Diagnosis of end stage liver disease
- •Any unstable medical condition
- •Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement
- •Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement
研究组 & 干预措施
Alda-341 treatment
Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery.
干预措施: Alda-341 (Drug)
结局指标
主要结局
Bioavailability of Alda-341 in salivary gland tissue using GCMS
时间窗: 2 week
Bio availability of Alda-341 in salivary gland tissue will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL.
次要结局
- Bioavailability of Alda-341 in saliva and blood(2 week)