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Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States — PK/PD  

Healthy Clinical Trial

Official title:
Pharmacokinetic and Pharmacodynamic Study of Oral Quercetin and Isoquercetin in Healthy Adults and Patients With Hypercoagulable States.

Clinical Trial Summary

The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase. Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with evidence of antiphospholipid antibodies

Clinical Trial Description

To compare the absorption and activity of quercetin or isoquercetin with or without ascorbic acid in healthy adults. Oral chews containing quercetin (500mg) or isoquercetin(500 mg total) with or without ascorbic acid will be given. Pharmacokinetic parameters (AUC, Cmax, Tmax, elimination half-life) will be determined over 24 hours (8 time points). Pharmacodynamic inhibition of protein disulfide isomerase activity will also be assessed.

In addition to healthy subjects, a cohort of 10 individuals with antiphospholipid antibodies will participate. These participants will receive isoquercetin 1000 mg and have pharmacodynamics studies performed at time 0 and 4 hours.

All study drugs will be provided by Quercegen Pharma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01722669
Study type Interventional
Source Beth Israel Deaconess Medical Center
Contact
Status Completed
Phase Early Phase 1
Start date May 2012
Completion date December 2019
View Details
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