Clinical trial NCT02056743: Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 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
measure: Area under the plasma concentration curve (AUClast)
timeFrame: 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:
measure: Area under the plasma concentration curve (AUCinf)
timeFrame: 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
measure: First time to reach Cmax (Tmax)
timeFrame: 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
measure: Terminal half-life (t1/2)
timeFrame: 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
measure: Apparent Total Body Clearance (CL/F)
timeFrame: 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
measure: Apparent Volume of Distribution (Vd/F)
timeFrame: 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:
measure: AUClast ratio
timeFrame: Up to last analysis time of each drug and concentration ratio of drug/metabolite in plasma and urine samples of various sampling time
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center of Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Laboratory medicine
name: Dal-Sik Kim, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Research Institute
name: Min-Gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.