HealthyPhase 1NCT02056743
Clinical Trials on Evaluate the Red Ginseng and Fermented-Red Ginseng Affect to Drug Metabolizing Enzyme and Transporter in Healthy Volunteers
A Phase 1 study testing CYP cocktail, Fexofenadine 30mg and Red ginseng in people with Healthy, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CYP cocktail, Fexofenadine 30mg and Red ginseng
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center of Chonbuk National University Hospital
Jeonju, Jeollabuk-do
About this study
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
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.
- Conditions
- Healthy
- Being tested
- CYP cocktail, Fexofenadine 30mg, Red ginseng, Fermented-red ginseng
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP cocktailDrug
Also called Caffeine 200mg, Losartan 50mg, Omeprazole 20mg, Dextromethorphan 30mg
Each group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions.
Fexofenadine 30mgDrug
Each group administered Fexofenadine 30mg under fasting conditions.
Red ginsengDietary supplement
During 4~17th days, end of the period 1, the group of red ginseng administered red ginseng extract.
Fermented-red ginsengDietary supplement
During 4~17th days, end of the period 1, the group of fermented-red ginseng administered fermented-red ginseng extract.
| Study group | Role | What they receive |
|---|---|---|
| Fermented-red ginseng | Experimental | 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. Receives: Drug: CYP cocktail; Drug: Fexofenadine 30mg; Dietary Supplement: Fermented-red ginseng |
| Red ginseng | Experimental | 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. Receives: Drug: CYP cocktail; Drug: Fexofenadine 30mg; Dietary Supplement: Red ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: 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)
Measured: 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 (5)
Area under the plasma concentration curve (AUCinf)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dal-Sik Kim, Chonbuk National University Hospital
- Investigators
- Dal-Sik Kim, PhD, MD, Principal investigator, Laboratory medicineMin-Gul Kim, MD, Principal investigator, Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056743
- Sponsor's protocol ID
- CUH_2012_RG
- Status last verified
- Oct 2013
- First submitted
- 2 Feb 2014
- Last updated
- 6 Feb 2014
- Results posted
- No
Publications
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.
PubMed 27746690Kim 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.
PubMed 27495955
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02056743
- Acronym / sponsor ID
- CUH_2012_RG
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented-red ginseng | Experimental | Drug: CYP cocktail, Drug: Fexofenadine 30mg, Dietary Supplement: Fermented-red ginsengAt 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. |
| Red ginseng | Experimental | Drug: CYP cocktail, Drug: Fexofenadine 30mg, Dietary Supplement: Red ginsengAt 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYP cocktailAlso: Caffeine 200mg, Losartan 50mg, Omeprazole 20mg, Dextromethorphan 30mgEach group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions. | Drug | Fermented-red ginseng, Red ginseng |
| Fexofenadine 30mgEach group administered Fexofenadine 30mg under fasting conditions. | Drug | Fermented-red ginseng, Red ginseng |
| Red ginsengDuring 4~17th days, end of the period 1, the group of red ginseng administered red ginseng extract. | Dietary supplement | Red ginseng |
| Fermented-red ginsengDuring 4~17th days, end of the period 1, the group of fermented-red ginseng administered fermented-red ginseng extract. | Dietary supplement | Fermented-red ginseng |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Derived from this study: PubMed 27746690Kim 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.
- Derived from this study: PubMed 27495955Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dal-Sik Kim, PhD, MD principal investigator
Laboratory medicine
Min-Gul Kim, MD principal investigator
Biomedical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYP cocktail, Fexofenadine 30mg and Red ginseng in people with Healthy, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02056743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.