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| Name | Class |
|---|---|
| Rural Development Administration, Korea | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black bean seed coat extract | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black bean seed coat extract | Other | 1000 mg oral daily dose for 2 weeks |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | for 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Seok Yim, M.D., PhD. | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St.Mary's Hospital | Seoul | 137-701 | South Korea |
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