A randomized, open-label, parallel-group study to evaluate the safety and pharmacokinetic characteristics in Korean healthy subjects
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0003740
- Lead Sponsor
- Korea Yakult Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1) Healthy adults between 20 and 45 years of age male, female
2) A person over 55kg in weight and within ± 20 percent of ideal body weight
3) A person has agreed to participate in clinical trial before the start of the trial and has signed an informed consent
1) A person taking antibiotics one month before taking investigational product
2) A person taking Antidiarrhea or Probiotics one month before taking investigational product
3) A person with suspected acute illness within 4 weeks before taking investigational product
4) A person with a history of gastrointestinal disease or gastrointestinal resection that may affect the absorption of investigational product
5) A person with a clinically relevant disease
6) A person with a history of gastric ulcer or duodenal ulcer in the past or a person with active duodenal ulcer
7) Any of the following
a. AST (SGOT) or ALT (SGPT)> 1.5 times the upper limit of the normal range of the laboratory
b. Total bilirubin> 1.5 times the upper limit of the normal range of the laboratory
8) A person with clinically relevant allergic diseases
9) A person with hypersensitivity to red ginseng products
10) A person taking ginseng and red ginseng products within 2 weeks before taking investigational product
11) A person participating in other clinical trials within 90 days before taking investigational product
12) A person taking medication that affects drug metabolism enzymes within 30 days prior to ingestion of the clinical trial or those taking drugs that will affect the clinical trial within 10 days or within 5 times of the half-life
13) A person has hypotensive or hypertensive during the screening test
14) A person with increased ocular pressure or suffering from diseases such as glaucoma or urine retention.
15) A person taking food that could affect the intake within 7 days before taking investigational product
16) A person can not eat meals given by the hospital
17) A person who donating blood within 60 days before taking investigational product or donating blood within 30 days
18) Continuous caffeine intake (caffeinated drinks> 5 cups / day) or a person who can not giving up drinking or excessive smokers (cigarettes> 10ea/day)
19) Pregnant or who has a pregnancy plan during this trial
20) A person who is deemed by the examiner to be ineligible for clinical trials
21) Illiterate
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ginsenoside Rd;Protopanaxatriol;Compound K;Ginsenoside Rg3;Ginsenoside Rh1;Ginsenoside F2
- Secondary Outcome Measures
Name Time Method