A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Mulberry Fruit Extract (C3G)

December 13, 2010 updated by: Seoul St. Mary's Hospital

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 Mulberry fruit extract.

This study, as an exploratory trial, does not required statistical hypothesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mulberry fruit extract
Daily 1000 mg oral Mulberry fruit extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1.
Other: Mulberry fruit extract
1000 mg oral daily dose for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax - Maximum Observed Concentration - C3G in Plasma
Time Frame: Blood samples collected over 6 hours
Blood samples collected over 6 hours
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
Blood samples collected over 6 hours
Antioxidative markers
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: for 4 weeks
for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

Rural Development Administration, Korea

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

December 14, 2010

Last Update Submitted That Met QC Criteria

December 13, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPT2010-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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