Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- AUC: the area under the concentration-time curve
研究概览
简要总结
This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.
The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female aged 21-65 years
- •healthy, good physical condition
- •voluntary, written, informed consent to participate in the study.
排除标准
- •use of anti-inflammatory or non-steroidal anti-inflammatory drugs
- •previous history of cardiovascular disease or acute or chronic inflammatory disease
- •use of antioxidant supplements or cholesterol-lowering agents
- •change of diet habits or lifestyle (diet, physical activity, etc.)
- •alcohol or substance abuse history
- •use of nicotine or tobacco
- •participation in another investigational study
结局指标
主要结局
AUC: the area under the concentration-time curve
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing glutathione.
Tmax: the time point of maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing glutathione.
Cmax: maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing glutathione.
次要结局
- White blood cell count (WBC)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Aspartate aminotransferase (AST)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Alkaline phosphatase (ALP)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Serum creatinine(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Platelet count(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- High-density lipoprotein (HDL) cholesterol(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Triglycerides(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Alanine aminotransferase (ALT)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Bilirubin(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- C-reactive protein (CRP)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Fasting blood glucose(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Low-density lipoprotein (LDL) cholesterol(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Hemoglobin (Hb)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Blood urea nitrogen (BUN)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Glomerular filtration rate (GFR)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Hematocrit (Hct)(0 (baseline; pre-dose), week 2 and week 4 (post-dose))
- Total cholesterol(0 (baseline; pre-dose), week 2 and week 4 (post-dose))