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Completed

NCT Number: NCT01230281

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

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

Completed

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Key information

Conditions

Oxidative Stress

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St.Mary's Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Black bean seed coat extract

Other

1000 mg oral daily dose for 2 weeks

Primary outcomes

  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 outcomes

  1. Number of Participants with Adverse Events

    Time frame: for 4 weeks

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • Rural Development Administration, Korea

Registry information

Acronym: C3G

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2010
Registry last updated
Dec 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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