PharmacokineticsNCT03136770
A Randomized, Open-label, Two-way Crossover Study to Assess the Pharmacokinetics and Safety of CK-30 600 mg (Compound K)
A study testing CK-30 and Red ginseng extracts in people with Pharmacokinetics, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A study to assess the pharmacokinetics and safety of CK-30 600 mg (Compound K) and red ginseng extracts 2.94 g after a single oral dose in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- CK-30 and Red ginseng extracts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2017to 10 Apr 2017
- Phase
- Interventional
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male Koreans between 19 and 45 years of age at the screening
- A body weight of greater than 55 kg, and a body mass index (BMI) of between 18.0 and 27.0, wherein BMI (kg/m2) = Weight (kg) / [Height (m)]2
- Full understanding of all the information regarding this clinical trial after listening to a detailed explanation, deciding to participate in the clinical trial by one's own will, and signing a written consent to comply with the precautions
Who cannot join
- History of herbal medicine including ginseng and red ginseng extracts within 2 weeks before the first administration of the IP
- Present condition or history of any clinically significant disease in the liver, nervous system, immune system, respiratory system, or endocrine system; hematologic or oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc.)
- Clinical evidence or history of gastrointestinal disease (including Crohn's disease, gastric ulcer, and acute or chronic pancreatitis) or history of gastrointestinal surgery (except for appendectomy or hernia surgery) that could affect the pharmacokinetic and safety assessment of the IP
- Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
- History of hypersensitivity, including drug allergy (red ginseng extracts, aspirin, antibiotics, etc.), or history of clinically significant hypersensitivity
- Meeting the following criteria at the screening: Serum AST (SGOT) or ALT (SGPT) > 1.5 times the upper normal limit
Show all 16Show fewer
- History of drug abuse, or a positive reaction to an abusive drug in a urine drug screening
- Having taken any prescribed medicine or herbal supplement within two weeks before the first administration of the IP, or any non-prescribed medicine or vitamin supplement within one week before the first administration of the IP (If the other conditions were satisfied, the subject could be deemed eligible for the trial at the discretion of the investigator.)
- Participation in and administration of the IP of another clinical trial within three months before the first administration of the IP
- Donation of a unit of blood within two months, or of blood components within one month, or receipt of a blood transfusion within one month before the first administration of the IP
- Consumption of more than 21 units of alcohol per week (one unit being 10 g of pure alcohol) or inability to abstain from drinking alcohol during the study period
- History of smoking 10 cigarettes per day within three months before the first administration of the IP (Subjects who quit smoking for at least three months before the first administration of the IP can still be enrolled in the trial.) or subjects who are not able to quit smoking from 24 hours before hospitalization to discharge.
- Consumption of grapefruit-containing products within 24 hours before the hospitalization or inability to abstain from consuming grapefruit-containing products during the study period
- Subjects who are not able to abstain from drinking caffeine-containing products (coffee, tea), carbonated drinks, nutrient tonics during the study period
- For females, plan to conceive or become pregnant, or inability to use an appropriate method of contraception (e.g., sterilization operation of the subject or his partner, intrauterine device of the partner, a barrier contraceptive method, or a combination of the diaphragm and condom methods) during the study period
- Assessment as ineligible by the investigator based on the results of the clinical laboratory tests or other assessments
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trials Center
Seoul, 110-744
About this study
Official title: A Randomized, Open-label, Two-way Crossover Study to Assess the Pharmacokinetics and Safety of CK-30 600 mg (Compound K) and Red Ginseng Extracts 2.94 g After a Single Oral Dose in Healthy Male Volunteers
A study to assess the pharmacokinetics and safety of CK-30 600 mg (Compound K) and red ginseng extracts 2.94 g after a single oral dose in healthy male volunteers
- Conditions
- Pharmacokinetics
- Being tested
- CK-30, Red ginseng extracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-30Dietary supplement
Compound K 600 mg
Red ginseng extractsDietary supplement
Red ginseng extracts 2.94 g
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | CK-30 600 mg -> red ginseng extracts 2.94 g Receives: Dietary Supplement: CK-30; Dietary Supplement: Red ginseng extracts |
| B | Experimental | red ginseng extracts 2.94 g -> CK-30 600 mg Receives: Dietary Supplement: CK-30; Dietary Supplement: Red ginseng extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Cmax)
Pharmacokinetics of CK-30 and Red ginseng extracts
Measured: Total 16 days
Pharmacokinetics (AUClast)
Pharmacokinetics of CK-30 and Red ginseng extracts
Measured: Total 16 days
Secondary outcomes (1)
Safety and tolerability (Number of participants with treatment-related adverse events)
Safety of CK-30 and Red ginseng extracts
Measured: Total 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start15 Feb 2017
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Jin Jang, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136770
- Sponsor's protocol ID
- CK-30
- Status last verified
- Apr 2017
- First submitted
- 31 Jan 2017
- Last updated
- 2 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jin H, Seo JH, Uhm YK, Jung CY, Lee SK, Yim SV. Pharmacokinetic comparison of ginsenoside metabolite IH-901 from fermented and non-fermented ginseng in healthy Korean volunteers. J Ethnopharmacol. 2012 Jan 31;139(2):664-7. doi: 10.1016/j.jep.2011.11.052. Epub 2011 Dec 9.
PubMed 22178175
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-way Crossover Study to Assess the Pharmacokinetics and Safety of CK-30 600 mg (Compound K) and Red Ginseng Extracts 2.94 g After a Single Oral Dose in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03136770
- Acronym / sponsor ID
- CK-30
- Conditions
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
A study to assess the pharmacokinetics and safety of CK-30 600 mg (Compound K) and red ginseng extracts 2.94 g after a single oral dose in healthy male volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: CK-30, Dietary Supplement: Red ginseng extractsCK-30 600 mg -> red ginseng extracts 2.94 g |
| B | Experimental | Dietary Supplement: CK-30, Dietary Supplement: Red ginseng extractsred ginseng extracts 2.94 g -> CK-30 600 mg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male Koreans between 19 and 45 years of age at the screening
- A body weight of greater than 55 kg, and a body mass index (BMI) of between 18.0 and 27.0, wherein BMI (kg/m2) = Weight (kg) / [Height (m)]2
- Full understanding of all the information regarding this clinical trial after listening to a detailed explanation, deciding to participate in the clinical trial by one's own will, and signing a written consent to comply with the precautions
Key exclusion criteria (16 listed)
- History of herbal medicine including ginseng and red ginseng extracts within 2 weeks before the first administration of the IP
- Present condition or history of any clinically significant disease in the liver, nervous system, immune system, respiratory system, or endocrine system; hematologic or oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc.)
- Clinical evidence or history of gastrointestinal disease (including Crohn's disease, gastric ulcer, and acute or chronic pancreatitis) or history of gastrointestinal surgery (except for appendectomy or hernia surgery) that could affect the pharmacokinetic and safety assessment of the IP
- Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
- History of hypersensitivity, including drug allergy (red ginseng extracts, aspirin, antibiotics, etc.), or history of clinically significant hypersensitivity
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 |
|---|---|---|
| CK-30Compound K 600 mg | Dietary supplement | A, B |
| Red ginseng extractsRed ginseng extracts 2.94 g | Dietary supplement | A, B |
Primary outcome
Pharmacokinetics (Cmax)
Time frame: Total 16 days
Pharmacokinetics of CK-30 and Red ginseng extracts
Pharmacokinetics (AUClast)
Time frame: Total 16 days
Pharmacokinetics of CK-30 and Red ginseng extracts
1 secondary outcome
Safety and tolerability (Number of participants with treatment-related adverse events)
Time frame: Total 16 days
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 2 May 2017.
- Results publication: PubMed 22178175Jin H, Seo JH, Uhm YK, Jung CY, Lee SK, Yim SV. Pharmacokinetic comparison of ginsenoside metabolite IH-901 from fermented and non-fermented ginseng in healthy Korean volunteers. J Ethnopharmacol. 2012 Jan 31;139(2):664-7. doi: 10.1016/j.jep.2011.11.052. Epub 2011 Dec 9.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CK-30 and Red ginseng extracts in people with Pharmacokinetics, run by Seoul 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 3 inclusion and 16 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 2 May 2017. 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.
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?
Pharmacokinetics (Cmax) (time frame: Total 16 days). 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 NCT03136770, which also lists 1 linked publication.
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 2 May 2017.