Pharmacokinetics of Resveratrol Comprising Products

May 1, 2013 updated by: Fruitura Bioscience Ltd.

Randomized Three-way Cross-over Comparative Pharmacokinetic Study of Resveratrol Comprising Products in Fasting Healthy Subjects

This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC) containing resveratrol compared with a reference. RGC will be administered as single oral dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total conjugates will be analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel, 84101
        • BioStudies Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Ages 18-55 years;
  • BMI >/= 19 and </= 30
  • non smoking
  • without history or evidence of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal disease
  • normal physical and laboratory examinations

Exclusion Criteria:

  • History or evidence of alcohol or drug abuse
  • subjects receiving chronic medication
  • unusual dietary habits or a recent change in body weight
  • acute medical situation 48 hours prior to initiation of the study
  • poor venous access
  • Subjects participated in a trial or donated blood within 4 weeks before initiation of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RGC1
RGC containing the equivalent of 50 mg resveratrol
Dietary supplement: RGC
Active Comparator: Resveratrol
The equivalent of 150 mg resveratrol
Dietary supplement: Resveratrol
The equivalent of 150 mg resveratrol
Other Names:
  • Transmax (Biotivia Ltd.)
Experimental: RGC2
RGC containing the equivalent of 150 mg resveratrol
Dietary supplement: RGC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual plasma concentrations of free and conjugated resveratrol
Time Frame: 24 hours
Pharmacokinetic data such as the peak plasma concentration (Cmax), time to peak (Tmax) ans area under the concentration-time curves (AUCt) will be reported.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fruitura Bioscience Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

December 9, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 1, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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