NCT02056743

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
Last Updated

February 6, 2014

Status Verified

October 1, 2013

Enrollment Period

1 month

First QC Date

February 2, 2014

Last Update Submit

February 4, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Fermented-red ginseng

EXPERIMENTAL

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 cocktailDrug: Fexofenadine 30mgDietary Supplement: Fermented-red ginseng

Red ginseng

EXPERIMENTAL

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 cocktailDrug: Fexofenadine 30mgDietary Supplement: Red ginseng

Interventions

CYP cocktailDRUG

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

Also known as: Caffeine 200mg, Losartan 50mg, Omeprazole 20mg, Dextromethorphan 30mg, Midazolam 7.5mg
Fermented-red ginsengRed ginseng
Fexofenadine 30mgDRUG

Each group administered Fexofenadine 30mg under fasting conditions.

Fermented-red ginsengRed ginseng
Red ginsengDIETARY_SUPPLEMENT

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

Red ginseng
Fermented-red ginsengDIETARY_SUPPLEMENT

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

Fermented-red ginseng

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center of Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 27746690DERIVED

  • 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.

    PMID: 27495955DERIVED

MeSH Terms

Interventions

CaffeineLosartanOmeprazoleDextromethorphanMidazolamfexofenadineAsian ginseng

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazoles2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridinesBenzimidazolesMorphinansOpiate AlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsBenzodiazepinesBenzazepines

Study Officials

  • Dal-Sik Kim, PhD, MD

    Laboratory medicine

    PRINCIPAL INVESTIGATOR

  • Min-Gul Kim, MD

    Biomedical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

February 2, 2014

First Posted

February 6, 2014

Study Start

September 1, 2013

Primary Completion

October 1, 2013

Last Updated

February 6, 2014

Record last verified: 2013-10

Locations

KR(1)