Clinical Research Directory

Pharmacokinetic Characterization of Tartaric Acid in Humans

Sponsor: Fundacion Clinic per a la Recerca Biomédica

Summary

The goal of this clinical trial is to characterize the pharmacokinetics (absorption, distribution, metabolism, and excretion; ADME) and oral bioavailability of tartaric acid in humans after its administration through different food matrices (red wine, fresh grapes, and grape juice). The study aims to determine whether the pharmacokinetic behavior of tartaric acid is matrix-dependent and dose-dependent in healthy adult volunteers. The main questions it aims to answer are: Does the food matrix (wine, grapes, or grape juice) influence the oral bioavailability of tartaric acid? Are there differences in key pharmacokinetic parameters of tartaric acid, including maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), total exposure (AUC), half-life (t1/2), and urinary excretion, depending on the matrix of intake? Researchers will compare the pharmacokinetic profiles of tartaric acid after consumption in red wine, grapes, and grape juice to evaluate differences in absorption, systemic exposure, and elimination attributable to the source of intake. Participants will: Follow a polyphenol-restricted diet prior to the study, including avoidance of grapes, wine, and related products. Consume a single standardized dose of tartaric acid administered as red wine, fresh grapes, or grape juice after an overnight fast. Provide blood samples at multiple time points over a 24-hour period to determine plasma tartaric acid concentrations. Collect urine samples over 24 hours for assessment of tartaric acid excretion. Consume standardized low-polyphenol meals under controlled conditions during the study day.

Official title: Pharmacokinetic Characterization of Tartaric Acid in Humans: Effect of the Food Matrix (Wine, Grapes, and Juice) on Its Bioavailability

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