A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract
Not Applicable
Completed
- Conditions
- Oxidative Stress
- Interventions
- Other: Black bean seed coat extract
- Registration Number
- NCT01230281
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Black bean seed coat extract 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of Participants with Adverse Events for 4 weeks
Trial Locations
- Locations (1)
Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of