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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

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ClinicalTrials.gov Identifier: NCT02056743
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Dal-Sik Kim, Chonbuk National University Hospital

Tracking Information
First Submitted Date  ICMJE February 2, 2014
First Posted Date  ICMJE February 6, 2014
Last Update Posted Date February 6, 2014
Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • Maximum plasma concentration (Cmax) [ Time Frame: 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) [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • Area under the plasma concentration curve (AUCinf) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 4, 2014)
AUClast ratio [ Time Frame: 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: CYP cocktail
    • Drug: Fexofenadine 30mg
    • Dietary Supplement: Fermented-red ginseng
  • 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.

    Interventions:
    • Drug: CYP cocktail
    • Drug: Fexofenadine 30mg
    • Dietary Supplement: Red ginseng
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2014)
30
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056743
Other Study ID Numbers  ICMJE CUH_2012_RG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dal-Sik Kim, Chonbuk National University Hospital
Study Sponsor  ICMJE Chonbuk National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dal-Sik Kim, PhD, MD Laboratory medicine
Principal Investigator: Min-Gul Kim, MD Biomedical Research Institute
PRS Account Chonbuk National University Hospital
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP