Pharmacokinetics of Resveratrol Comprising Products

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fruitura Bioscience Ltd.
ClinicalTrials.gov Identifier:
NCT01747252
First received: December 9, 2012
Last updated: May 1, 2013
Last verified: May 2013

December 9, 2012
May 1, 2013
August 2012
October 2012   (final data collection date for primary outcome measure)
Individual plasma concentrations of free and conjugated resveratrol [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Pharmacokinetic data such as the peak plasma concentration (Cmax), time to peak (Tmax) ans area under the concentration-time curves (AUCt) will be reported.
Same as current
Complete list of historical versions of study NCT01747252 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics of Resveratrol Comprising Products
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Healthy
  • Dietary Supplement: RGC
  • Dietary Supplement: Resveratrol
    The equivalent of 150 mg resveratrol
    Other Name: Transmax (Biotivia Ltd.)
  • Experimental: RGC1
    RGC containing the equivalent of 50 mg resveratrol
    Intervention: Dietary Supplement: RGC
  • Active Comparator: Resveratrol
    The equivalent of 150 mg resveratrol
    Intervention: Dietary Supplement: Resveratrol
  • Experimental: RGC2
    RGC containing the equivalent of 150 mg resveratrol
    Intervention: Dietary Supplement: RGC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2013
October 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01747252
08/12
No
Fruitura Bioscience Ltd.
Fruitura Bioscience Ltd.
Not Provided
Not Provided
Fruitura Bioscience Ltd.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP