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

NCT ID: NCT02056743

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CYP cocktail

Intervention Type: DRUG

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

Fexofenadine 30mg

Intervention Type: DRUG

Each group administered Fexofenadine 30mg under fasting conditions.

Fermented-red ginseng

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: EXPERIMENTAL

CYP cocktail

Intervention Type: DRUG

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

Fexofenadine 30mg

Intervention Type: DRUG

Each group administered Fexofenadine 30mg under fasting conditions.

Red ginseng

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

CYP cocktail

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

Intervention Type: DRUG

Fexofenadine 30mg

Each group administered Fexofenadine 30mg under fasting conditions.

Intervention Type: DRUG

Red ginseng

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

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Caffeine 200mg; Losartan 50mg; Omeprazole 20mg; Dextromethorphan 30mg; Midazolam 7.5mg

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dal-Sik Kim

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dal-Sik Kim, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Laboratory medicine

Min-Gul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Institute

Locations

Clinical Trial Center of Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

References

Kim DS, Kim Y, Jeon JY, Kim MG. Effect of Red Ginseng on cytochrome P450 and P-glycoprotein activities in healthy volunteers. J Ginseng Res. 2016 Oct;40(4):375-381. doi: 10.1016/j.jgr.2015.11.005. Epub 2015 Dec 17.

Reference Type: DERIVED

PMID: 27746690 (View on PubMed)

Kim MG, Kim Y, Jeon JY, Kim DS. Effect of fermented red ginseng on cytochrome P450 and P-glycoprotein activity in healthy subjects, as evaluated using the cocktail approach. Br J Clin Pharmacol. 2016 Dec;82(6):1580-1590. doi: 10.1111/bcp.13080. Epub 2016 Oct 9.

Reference Type: DERIVED

PMID: 27495955 (View on PubMed)

Other Identifiers

CUH_2012_RG

Identifier Type: -

Identifier Source: org_study_id