Korean J Physiol Pharmacol.  2012 Aug;16(4):249-253. 10.4196/kjpp.2012.16.4.249.

The Safety and Pharmacokinetics of Cyanidin-3-Glucoside after 2-Week Administration of Black Bean Seed Coat Extract in Healthy Subjects

• Jeon S
• Han S
• Lee J
• Hong T
• Yim DS

• KMID: 2011159
• DOI: http://doi.org/10.4196/kjpp.2012.16.4.249

Abstract

We analyzed the pharmacokinetics of C3G on data from twelve subjects, after 2-week multiple dosing of black bean (Phaseolus vulgaris, Cheongjakong-3-ho) seed coat extract, using the mixed effect analysis method (NONMEM, Ver. 6.2), as well as the conventional non-compartmental method. We also examined the safety and tolerability. The PK analysis used plasma concentrations of the C3G on day 1 and 14. There was no observed accumulation of C3G after 2-week multiple dosing of black bean seed coat extract. The typical point estimates of PK were CL (clearance)=3,420 l/h, V (volume)=7,280 L, Ka (absorption constant)=9.94 h(-1), ALAG (lag time)=0.217 h. The black bean seed coat extract was well tolerated and there were no serious adverse events. In this study, we confirmed that a significant amount of C3G was absorbed in human after given the black bean seed coat extract.

Keyword

Anthocyanin; Clinical trial; C3G; Pharmacokinetics; Phaseolus vulgaris

MeSH Terms

Anthocyanins
Glucosides
Humans
Phaseolus
Plasma
Seeds
Anthocyanins
Glucosides

Figure

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  Fig. 1 Goodness-of-fit plots for the final population PK model of C3G. Black line, line of identity; gray line, LOESS (locally weighted regression smooth line). IWRES, individual weighted residuals.

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  Fig. 2 Visual predictive check plots of the final PK model; 1,000 virtual patients (1,000 datasets) were simulated using the final PK parameter estimates.

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