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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03136770
Other study ID # CK-30
Secondary ID
Status Completed
Phase N/A
First received January 31, 2017
Last updated April 27, 2017
Start date February 15, 2017
Est. completion date April 10, 2017

Study information

Verified date April 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 10, 2017
Est. primary completion date April 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
CK-30
Compound K 600 mg
Red ginseng extracts
Red ginseng extracts 2.94 g

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Clinical Trials Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (Cmax) Pharmacokinetics of CK-30 and Red ginseng extracts Total 16 days
Primary Pharmacokinetics (AUClast) Pharmacokinetics of CK-30 and Red ginseng extracts Total 16 days
Secondary Safety and tolerability (Number of participants with treatment-related adverse events) Safety of CK-30 and Red ginseng extracts Total 16 days
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