Clinical trial NCT02321176: Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its Three Metabolites in Human Eyes and Blood
Official title: Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its Three Metabolites in Human Eyes and Blood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eye Disease
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with rhegmatogenous retinal detachment.
2. Male and female patients 18-60 years of age.
3. nonsmokers or who smoke\<10 cigarettes/day.
4. BMI ranging from 19 to 30 kg/m\^2 were eligible for the study.
5. 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.
6. Women use measures to avoid conception during the study period (e.g. oral contraceptives, intrauterine devices \[IUDs\], and condoms).
7. 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.
8. patients should abstain from alcohol-containing beverages at least two days prior to and during the study.

Exclusion Criteria:

1. Uncontrolled Blood pressure exceeding diastolic pressure of 100 mm Hg (sitting) during the screening period and uncontrolled diabetes mellitus
2. Participation in another simultaneous medical investigation or trial
3. 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.
4. 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.
5. 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).
6. 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).

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Primary outcomes:
measure: Tmax
timeFrame: up to three days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Medical College of HUST
state: Hubei
Study officials:
affiliation: Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology
name: Sun Xufang
role: STUDY_DIRECTOR
References: