Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its Three Metabolites in Human Eyes and Blood

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

Study Overview

• Status: Unknown
• Conditions: Eye Disease
• Intervention / Treatment: Drug: trans-resveratrol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Shuaishuai; Phone Number: 15623422892; Email: 949990624@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Medical College of HUST
      • Contact: Shuaishuai Wang; Phone Number: 15623422892; Email: 949990624@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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 Names: LONGEVINEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	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.	up to three days

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Director: Sun Xufang, Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): April 1, 2015
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: June 7, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Estimate): December 22, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: Sun2