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Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers

NCT02056743 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-02-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the possibility of drug interactions before and after taking red ginseng or fermented-red ginseng by estimating metabolic rate of indicator drugs for cytochrome P450 and P-glycoprotein.

Conditions

  • Healthy

Interventions

DRUG

CYP cocktail

Each group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions.

DRUG

Fexofenadine 30mg

Each group administered Fexofenadine 30mg under fasting conditions.

DIETARY_SUPPLEMENT

Red ginseng

During 4\~17th days, end of the period 1, the group of red ginseng administered red ginseng extract.

DIETARY_SUPPLEMENT

Fermented-red ginseng

During 4\~17th days, end of the period 1, the group of fermented-red ginseng administered fermented-red ginseng extract.

Sponsors & Collaborators

  • Chonbuk National University Hospital

    lead OTHER

Principal Investigators

  • Dal-Sik Kim, PhD, MD · Laboratory medicine

  • Min-Gul Kim, MD · Biomedical Research Institute

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02056743 on ClinicalTrials.gov