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

Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321176
• Other study ID #: Sun2
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2014
• Last updated: December 16, 2014
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2014
• Source: Huazhong University of Science and Technology
• Contact: Wang Shuaishuai
• Phone: 15623422892
• Email: 949990624[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Eye Disease
• Eye Diseases

Intervention

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

Locations

Country	Name	City	State
China	Tongji Medical College of HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes