KCT0006791
Completed
未知
A randomized, open-label, single-dose, crossover study to compare the safety, tolerability and pharmacokinetics of ginsenosides after oral administrations of fermented Red ginseng concentrate and Red ginseng concentrate in healthy volunteers
Kyung Hee University Hospital0 sites16 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kyung Hee University Hospital
- Enrollment
- 16
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subjects who agree to participate in this study and have given their written informed consent
- •2\) Men aged 19 to 45
- •3\) 55\.0 \= Body weight (kg) \= 90\.0 and 18\.0 \= BMI (kg/m2\) \< 27\.0
- •4\) Subject who was determined by investigator for eligibility in this study
Exclusion Criteria
- •1\) History of hepatic, gastrointestinal, circulatory, renal, respiratory, endocrine, neurologic, immunologic, hematologic, psychiatric system, neoplasm or tumor
- •2\) History or ongoing of significant allergy of prescription or over\-the\-counter medication
- •3\) History of gastrointestinal disease or operation which can affect absorption of IP (Except for appendectomy or hernia correction)
- •4\) Subject who meets any of the following criteria at screening test
- •? At the vital sign check, systolic blood pressure under 90 mmHg or over 150 mmHg, or diastolic blood pressure under 60 mmHg or over 100 mmHg
- •? Hepatic insufficiency (liver enzymes in the blood (AST and ALT) over 1\.5 times of upper limit of normal)
- •? At the electrocardiogram, QTc over 450 msec or manifestation or significant abnormal rhythm
- •5\) History of drug abuse
- •6\) Taking any prescription or traditional medication within 2 weeks or over\-the\-counter medication, dietary supplement or vitamins within 1 week before first investigational drug (IP) administration (but, in the investigator's judgment, when other conditions are suitable, the subject can participate in this trial.)
- •7\) Taking inducing or depressing drug metabolizing enzyme such as barbital within 1 month before first IP administration.
Outcomes
Primary Outcomes
Not specified
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