A Randomized, Double-blind, Cross-over Study to Assess the Bioavailability of Formulated Glutathione (F-GSH) in Comparison with Normal Unformulated Glutathione (UF-GSH) Supplementation in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To estimate the concentrations of formulated Glutathione (F-GSH) in comparison with normal unformulated Glutathione (UF-GSH) supplementation
研究概览
简要总结
This is a comparative, randomized, crossover study to compare the bioavailability of formulated glutathione (F-GSH) in comparison with normal unformulated glutathione (UF-GSH) supplementation. A group of 22 healthy volunteers willing to give a written informed consent will be screened on Visit 1 to confirm the eligibility. Subjects fulfilling the eligibility criteria will be randomized into 1 of the 2 treatment sequences on visit 2, followed by treatment sequence 2 on visit 3. There will be 1 washout period in between the 2 dosing days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 2.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
排除标准
- •1.Subjects who have consumed either glutathione (GSH) containing food/supplement 7 days prior to screening.2.Pregnant or lactating women.3.Subjects with known hypersensitivity to the investigational products.4.Subjects who have participated in any clinical trial in the past 1 month.5.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.6.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
结局指标
主要结局
To estimate the concentrations of formulated Glutathione (F-GSH) in comparison with normal unformulated Glutathione (UF-GSH) supplementation
时间窗: Baseline, Day 1 and Day 9
次要结局
- Pharmacokinetics parameters of F-GSH in comparison with UF-GSH supplementation(Baseline, Day 1 and Day 9)
- Safety and tolerability of F-GSH in comparison with UF-GSH supplementation.(Baseline, Day 1 and Day 9)
研究者
Jestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd