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

Oxidative Stress Clinical Trial

— C3G  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230268
• Other study ID #: CPT2010-05
• Status: Completed
• Phase: N/A
• First received: October 27, 2010
• Last updated: December 13, 2010
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2010
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 Mulberry fruit extract.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Other:
• Mulberry fruit extract
1000 mg oral daily dose for 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	Rural Development Administration, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - Maximum Observed Concentration - C3G in Plasma		Blood samples collected over 6 hours	No
Primary	AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma		Blood samples collected over 6 hours	No
Primary	Antioxidative markers		2 weeks	No
Secondary	Number of Participants with Adverse Events		for 4 weeks	Yes