Pharmacokinetics of Resveratrol Comprising Products

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747252
• Other study ID #: 08/12
• Status: Completed
• Phase: N/A
• First received: December 9, 2012
• Last updated: May 1, 2013
• Start date: August 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Fruitura Bioscience Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• RGC

• RGC

• Resveratrol
The equivalent of 150 mg resveratrol

Locations

Country	Name	City	State
Israel	BioStudies Center	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Fruitura Bioscience Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual plasma concentrations of free and conjugated resveratrol	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	No