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

• Sponsor: Seoul St. Mary's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01230281
• Collaborator: Rural Development Administration, Korea (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 12.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax - Maximum Observed Concentration - C3G in Plasma [Blood samples collected over 6 hours]

2. AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma [Blood samples collected over 6 hours]

3. Antioxidative markers [2 weeks]

Secondary Outcome Measures

1. Number of Participants with Adverse Events [for 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St.Mary's Hospital	Seoul		Korea, Republic of	137-701

Sponsors and Collaborators

• Seoul St. Mary's Hospital
• Rural Development Administration, Korea

Investigators

• Principal Investigator: Dong-Seok Yim, M.D., PhD., Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01230281
• Other Study ID Numbers: CPT2010-06
• First Posted: Oct 29, 2010
• Last Update Posted: Dec 14, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: C3G; Oxidative stress; Antioxidant; Black bean

Study Results

No Results Posted as of Dec 14, 2010