Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its Three Metabolites in Human Eyes and Blood
NCT ID: NCT02321176
Last Updated: 2014-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-03-31
2015-04-30
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
SINGLE
Study Groups
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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
trans-resveratrol
patients received 100mg Longevinex everyday,total of three days
1 capsule daily for one day containing 100 mg of trans resveratrol active ingredient
Interventions
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trans-resveratrol
patients received 100mg Longevinex everyday,total of three days
1 capsule daily for one day containing 100 mg of trans resveratrol active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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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18 Years
60 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Xufang Sun
Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its three Metabolites in Human Eyes and Blood
Principal Investigators
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Sun Xufang
Role: STUDY_DIRECTOR
Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology
Locations
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Tongji Medical College of HUST
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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ShuaiShuai Wang
Role: primary
Other Identifiers
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Sun2
Identifier Type: -
Identifier Source: org_study_id