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

NCT01230281 | Completed

• 1 other identifier: CPT2010-06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Oxidative Stress

Keywords

C3G; Oxidative stress; Antioxidant; Black bean

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants with Adverse Events

  for 4 weeks

Study Arms (1)

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.

Other: Black bean seed coat extract

Interventions

Black bean seed coat extract OTHER

1000 mg oral daily dose for 2 weeks

Black bean seed coat extract

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, 137-701, South Korea

Location

Study Officials

• Dong-Seok Yim, M.D., PhD.

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 14, 2010

Record last verified: 2010-10

Locations

KR (1)