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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

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056743


Locations
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Korea, Republic of
Clinical Trial Center of Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
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Principal Investigator: Dal-Sik Kim, PhD, MD Laboratory medicine
Principal Investigator: Min-Gul Kim, MD Biomedical Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dal-Sik Kim, Professor, MD, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT02056743    
Other Study ID Numbers: CUH_2012_RG
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: October 2013
Additional relevant MeSH terms:
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Fexofenadine
Losartan
Midazolam
Dextromethorphan
Caffeine
Omeprazole
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Phosphodiesterase Inhibitors