Pharmacokinetics of Resveratrol Comprising Products

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01747252
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : May 3, 2013
Information provided by (Responsible Party):
Fruitura Bioscience Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: RGC Dietary Supplement: Resveratrol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Randomized Three-way Cross-over Comparative Pharmacokinetic Study of Resveratrol Comprising Products in Fasting Healthy Subjects
Study Start Date : August 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

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 Name: Transmax (Biotivia Ltd.)

Experimental: RGC2
RGC containing the equivalent of 150 mg resveratrol
Dietary Supplement: RGC

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01747252

BioStudies Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Fruitura Bioscience Ltd.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fruitura Bioscience Ltd. Identifier: NCT01747252     History of Changes
Other Study ID Numbers: 08/12
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents