Pharmacokinetics of Resveratrol Comprising Products

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

BioStudies Center

Beersheba, 84101, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGC

Dietary Supplement

Resveratrol

Dietary Supplement

The equivalent of 150 mg resveratrol

Other names: Transmax (Biotivia Ltd.)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Fruitura Bioscience Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Dec 11, 2012
Registry last updated: May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed