Healthy
Conditions
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.
Interventions
DRUGCYP cocktail
Each group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions.
DRUGFexofenadine 30mg
Each group administered Fexofenadine 30mg under fasting conditions.
DIETARY_SUPPLEMENTRed ginseng
During 4\ 17th days, end of the period 1, the group of red ginseng administered red ginseng extract.
DIETARY_SUPPLEMENTFermented-red ginseng
During 4\ 17th days, end of the period 1, the group of fermented-red ginseng administered fermented-red ginseng extract.
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
South Korea
Outcome results
None listed