- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01230281
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract (C3G)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 137-701
- Seoul St.Mary's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Black bean seed coat extract
Daily 1000 mg oral Black bean seed coat extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1.
|
1000 mg oral daily dose for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax - Maximum Observed Concentration - C3G in Plasma
Time Frame: Blood samples collected over 6 hours
|
Blood samples collected over 6 hours
|
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma
Time Frame: Blood samples collected over 6 hours
|
Blood samples collected over 6 hours
|
Antioxidative markers
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events
Time Frame: for 4 weeks
|
for 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dong-Seok Yim, M.D., PhD., Seoul st. mary's hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CPT2010-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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