A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01230281

Acronym

C3G

Enrollment

Registered

2010-10-29

Start date

2010-11-30

Completion date

2010-12-31

Last updated

2010-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

C3G, Oxidative stress, Antioxidant, Black bean

Brief summary

This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured. Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg black bean seed coat extract. This study, as an exploratory trial, does not required statistical hypothesis

Interventions

OTHERBlack bean seed coat extract

1000 mg oral daily dose for 2 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Body weight \>55 kg for male, \>45 kg for female (within 80-120% of Ideal body weight) * Give written informed consent and voluntarily decide participation

Exclusion criteria

* Acute or chronic disease symptom on screening * Existing active and clinically significant disease involving more than one organ system * Known allergy to Mulberry or other berries * Positive drug or alcohol screening * Smokers of 10 or more cigarettes per day * Participation in a clinical trial during last 2 month prior to the start of the study * Pregnancy

Design outcomes

Primary

Measure	Time frame
Cmax - Maximum Observed Concentration - C3G in Plasma	Blood samples collected over 6 hours
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma	Blood samples collected over 6 hours
Antioxidative markers	2 weeks

Secondary

Measure	Time frame
Number of Participants with Adverse Events	for 4 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026