Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its Three Metabolites in Human Eyes and Blood
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tmax
研究概览
简要总结
There is blood-eye barrier in eyes,but some oral medicines can enter in the tissues of eyes.
The primary objective of the study is to study the Pharmacokinetics of Trans-resveratrol and Its three Metabolites in Human Eyes and Blood
详细描述
This was a single-blind, randomised study investigating single oral dose of LONGEVINEX in two groups of about 20 Patients with rhegmatogenous retinal detachment retinal detachment（males and females).The subjects received 100mg LONGEVINEX everyday,a total of three days before surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with rhegmatogenous retinal detachment.
- •Male and female patients 18-60 years of age.
- •nonsmokers or who smoke<10 cigarettes/day.
- •BMI ranging from 19 to 30 kg/m^2 were eligible for the study.
- •Patients were considered to be healthy on the basis of electrocardiogram (ECG), and clinical laboratory safety tests (haematology, plasma biochemistry, urinalysis and hepatitis B, hepatitis C and HIV serology) performed at screening.
- •Women use measures to avoid conception during the study period (e.g. oral contraceptives, intrauterine devices [IUDs], and condoms).
- •Avoid ingesting grapefruit, grapefruit juice or other grapefruit juice containing products, and any herbal-based nutrient supplement or prescribed medications( grapefruit, cranberry, blueberry products, peanuts and peanut butter, grape and grape products, and red wine ) during the same period of time.
- •patients should abstain from alcohol-containing beverages at least two days prior to and during the study.
排除标准
- •Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus
- •Participation in another simultaneous medical investigation or trial
- •Renal failure requiring dialysis or renal transplant or liver dysfunction History of other disease,or other findings giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications.5.IOP over 30 mmHg.
- •Any previous retinal laser photocoagulation to the study eye in treatment naive. Any previous intravitreal injection in study eye (triamcinolone or other) in treatment naive.
- •Any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery). Intracapsular cataract extraction (posterior capsule needs to be present).
- •Aphakia or absence of the posterior capsule in the study eye, Structural damage to the center of the macula in the study eye preexisting to CRVO likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s).
研究组 & 干预措施
pharmacokinetics,trans-resveratrol
tissues from the eyes of the surgery of patients who received 1 Longevinex containing 100 mg of trans resveratrol active ingredient brand capsule for three days
干预措施: trans-resveratrol (Drug)
结局指标
主要结局
Tmax
时间窗: up to three days
1 capsule containing 100 mg of trans resveratrol active ingredient daily for three days.Than detect the concentrations of the tissues from the eyes of the surgery.
次要结局
未报告次要终点
研究者
Xufang Sun
Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its three Metabolites in Human Eyes and Blood
Huazhong University of Science and Technology