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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230281
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : December 14, 2010
Sponsor:
Collaborator:
Rural Development Administration, Korea
Information provided by:
Seoul St. Mary's Hospital

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


Condition or disease Intervention/treatment Phase
Oxidative Stress Other: Black bean seed coat extract Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract
Study Start Date : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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.
Other: Black bean seed coat extract
1000 mg oral daily dose for 2 weeks




Primary Outcome Measures :
  1. Cmax - Maximum Observed Concentration - C3G in Plasma [ Time Frame: Blood samples collected over 6 hours ]
  2. 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 ]
  3. Antioxidative markers [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: for 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230281


Locations
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Korea, Republic of
Seoul St.Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Seoul St. Mary's Hospital
Rural Development Administration, Korea
Investigators
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Principal Investigator: Dong-Seok Yim, M.D., PhD. Seoul St. Mary's Hospital
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Responsible Party: Dong-Seok Yim, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01230281    
Other Study ID Numbers: CPT2010-06
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: December 14, 2010
Last Verified: October 2010
Keywords provided by Seoul St. Mary's Hospital:
C3G
Oxidative stress
Antioxidant
Black bean