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

NCT02321176 | Unknown DMC

• 1 other identifier: Sun2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

pharmacokinetics,trans-resveratrol

EXPERIMENTAL

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

Interventions

trans-resveratrol DRUG

patients received 100mg Longevinex everyday,total of three days 1 capsule daily for one day containing 100 mg of trans resveratrol active ingredient

Also known as: LONGEVINEX

pharmacokinetics,trans-resveratrol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Eye Diseases

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Sun Xufang

  Department of Ophthalmology,Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology

  STUDY DIRECTOR

Central Study Contacts

Wang Shuaishuai

CONTACT

15623422892; 949990624@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its three Metabolites in Human Eyes and Blood

Study Record Dates

• First Submitted: June 7, 2014
• First Posted: December 22, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 22, 2014

Record last verified: 2014-12

Locations

CN (1)