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Completed

NCT Number: NCT02056743

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

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.

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center of Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CYP cocktail

Drug

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

Fexofenadine 30mg

Drug

Each group administered Fexofenadine 30mg under fasting conditions.

Red ginseng

Dietary Supplement

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

Fermented-red ginseng

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
First posted
Feb 6, 2014
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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