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

Seoul St. Mary's Hospital

Status: Completed

Conditions: Oxidative Stress

Treatments: Other: Mulberry fruit extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01230268

CPT2010-05

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Mulberry fruit extract

Experimental group

Description:

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.

Treatment:

Other: Mulberry fruit extract