NCT01747252已完成不适用
Randomized Three-way Cross-over Comparative Pharmacokinetic Study of Resveratrol Comprising Products in Fasting Healthy Subjects
Fruitura Bioscience Ltd.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Individual plasma concentrations of free and conjugated resveratrol
研究概览
简要总结
This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC) containing resveratrol compared with a reference. RGC will be administered as single oral dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total conjugates will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages 18-55 years;
- •BMI >/= 19 and </= 30
- •non smoking
- •without history or evidence of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal disease
- •normal physical and laboratory examinations
排除标准
- •History or evidence of alcohol or drug abuse
- •subjects receiving chronic medication
- •unusual dietary habits or a recent change in body weight
- •acute medical situation 48 hours prior to initiation of the study
- •poor venous access
- •Subjects participated in a trial or donated blood within 4 weeks before initiation of the study
结局指标
主要结局
Individual plasma concentrations of free and conjugated resveratrol
时间窗: 24 hours
Pharmacokinetic data such as the peak plasma concentration (Cmax), time to peak (Tmax) ans area under the concentration-time curves (AUCt) will be reported.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets (Administered Three Times Daily)HealthyNCT01121900Labopharm Inc.26
已完成
1 期
Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy SubjectsHealthyNCT01776697Daewon Pharmaceutical Co., Ltd.
已完成
1 期
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Modified-Release Tablets 800 mgChronic PainNCT05329454Overseas Pharmaceuticals, Ltd.30
已完成
1 期
Clinical Trial to Investigate the Efficacy and Safety of DWJ1351HealthyNCT03753477Daewoong Pharmaceutical Co. LTD.64
已完成
1 期
Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-NS250 and IY-NT-SRPharmacokineticsPharmacodynamicsNCT06725992Il-Yang Pharm. Co., Ltd.56