NCT02056743

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

Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers; Open-label, Parallel Group

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chonbuk National University Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-10-01
• First posted: 2014-02-06
• Last updated: 2014-02-06

Locations

1 site across 1 country: South Korea