Pharmacokinetics Clinical Trial
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
Verified date | April 2017 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital Clinical Trials Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04092725 -
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04181008 -
Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
|
Early Phase 1 | |
Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
Completed |
NCT04406415 -
Oral Nafamostat in Healthy Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05421312 -
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
|
Phase 4 | |
Completed |
NCT02534753 -
A Pharmacokinetics Study of Intravenous Ascorbic Acid
|
Phase 1 | |
Completed |
NCT01976078 -
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
|
N/A | |
Completed |
NCT01682408 -
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
|
Phase 1 | |
Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
Completed |
NCT01214941 -
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
|
Phase 4 | |
Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
Phase 1 | |
Completed |
NCT01260025 -
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
|
Phase 1 | |
Completed |
NCT00856570 -
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01055964 -
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
|
Phase 3 | |
Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
Completed |
NCT01276119 -
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males
|
Phase 1 | |
Completed |
NCT00984009 -
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
|
Phase 1 | |
Completed |
NCT00746499 -
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
|
Phase 1 | |
Completed |
NCT00983242 -
Drug-Drug Interaction Between Colchicine and Verapamil ER
|
Phase 1 |