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

Sponsor

Chonbuk National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02056743

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: CYP cocktail Drug: Fexofenadine 30mg Dietary Supplement: Red ginseng Dietary Supplement: Fermented-red ginseng	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fermented-red ginseng At period 1, the fermented-red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the first day. At second day, they administered Fexofenadine 30mg under fasting conditions. During 4~17th days they administered fermented-red ginseng. At period 2, the fermented-red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the 15th day. At 16th day, they administered Fexofenadine 30mg under fasting conditions.	Drug: CYP cocktail Each group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions. Other Names: Caffeine 200mg Losartan 50mg Omeprazole 20mg Dextromethorphan 30mg Midazolam 7.5mg Drug: Fexofenadine 30mg Each group administered Fexofenadine 30mg under fasting conditions. 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.
Experimental: Red ginseng At period 1, the red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the first day. At second day, they administered Fexofenadine 30mg under fasting conditions. During 4~17th days they administered red ginseng. At period 2, the red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the 15th day. At 16th day, they administered Fexofenadine 30mg under fasting conditions.	Drug: CYP cocktail Each group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions. Other Names: Caffeine 200mg Losartan 50mg Omeprazole 20mg Dextromethorphan 30mg Midazolam 7.5mg 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.

Arm

Intervention/Treatment

Experimental: Fermented-red ginseng

At period 1, the fermented-red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the first day. At second day, they administered Fexofenadine 30mg under fasting conditions. During 4~17th days they administered fermented-red ginseng. At period 2, the fermented-red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the 15th day. At 16th day, they administered Fexofenadine 30mg under fasting conditions.

Drug: CYP cocktail

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

Other Names:

Caffeine 200mg

Losartan 50mg

Omeprazole 20mg

Dextromethorphan 30mg

Midazolam 7.5mg

Drug: Fexofenadine 30mg

Each group administered Fexofenadine 30mg under fasting conditions.

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.

Experimental: Red ginseng

At period 1, the red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the first day. At second day, they administered Fexofenadine 30mg under fasting conditions. During 4~17th days they administered red ginseng. At period 2, the red ginseng group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions on the 15th day. At 16th day, they administered Fexofenadine 30mg under fasting conditions.

Drug: CYP cocktail

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

Other Names:

Caffeine 200mg

Losartan 50mg

Omeprazole 20mg

Dextromethorphan 30mg

Midazolam 7.5mg

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.

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration (Cmax) [CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h]
Area under the plasma concentration curve (AUClast) [CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h]

Secondary Outcome Measures

Area under the plasma concentration curve (AUCinf) [CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h]
First time to reach Cmax (Tmax) [CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h]
Terminal half-life (t1/2) [CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h]
Apparent Total Body Clearance (CL/F) [CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h]
Apparent Volume of Distribution (Vd/F) [CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h]

Other Outcome Measures

AUClast ratio [Up to last analysis time of each drug and concentration ratio of drug/metabolite in plasma and urine samples of various sampling time]
CYP cocktail: 0, 0.25, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h / Fexofenadine: 0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 h / Urine for Losartan and Dextromethorphan: 0-4, 4-8, 8-12 h

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male subjects between the ages of 20 and 55 years.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 45 kg.
An informed consent document signed and dated by the subject.
Subject who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Any condition possibly affecting drug absorption (e.g. gastrectomy)
History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of Screening
Participating in a bioequivalence study or other clinical study within 3 months preceding the first dose of study medication
Screening sitting blood pressure > 160 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of rest.
History of significant alcohol abuse or drug abuse within one year prior to the Screening
Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing
Smoking over 20 cigarettes per day
Use of prescription or nonprescription drugs and dietary supplements within 10 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Blood donation within 2 months prior to dosing, or plasma donation within 2 weeks prior to dosing
Unwilling or unable to comply with the Lifestyle guidelines described in this protocol
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Subjects who are hypersensitive to investigational drugs or related compounds
Subjects with hereditary disease of galactose intolerance, Lapp lactase deficiency or gulucose-galactose malabsorption
Subjects who are decided incongruity to participated in this study by investigators