KCT0002418
Completed
N/A
A study to assess pharmacokinetic interactions by evaluating the effect of red ginseng on CYP drug metabolizing enzymes and transporter in healthy Korean adults
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Sponsor
- Kyungpook National University Hospital
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy Korean adult male aged \= 19 years at the screening
- •2\) body weight of \= 50kg and within ± 20% of ideal body weight
- •? IBW (kg) \= {height (cm) \- 100} \* 0\.9
- •3\) No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease
- •4\) Subject that is considered eligible for participating in the study by an investigator, based on clinical laboratory test (serology, hematology, clinical chemistry, urinalysis, etc.) and ECG, performed within 4 weeks prior to administration of study drug
- •5\) Subject who understands a detailed explanation of the study protocol, voluntarily decides to participate and follow the study instructions, and signs Informed Consent
Exclusion Criteria
- •1\) Hypersensitivity to study drug (major ingredient or any other ingredient), or medical history of clinically significant hypersensitivity to any other drug or additives
- •2\) Medical history that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hemato\-oncology, central nervous system, psychiatric and musculoskeletal system)
- •3\) History of gastrointestinal disease (e.g., inflammatory bowel disease, active peptic ulcer) or gastrointestinal surgery that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
- •4\) History of major injury, surgical operation, or suspected symptom of acute illness (severe infection, severe trauma, serious diarrhea or vomiting, etc.) within 4 weeks prior to the first administration of study drug
- •5\) Systolic blood pressure \= 140mmHg or \< 115mmHg, diastoic blood pressure \= 90mmHg or \< 70mmHg in sitting position
- •6\) History of a substance abuse
- •7\) Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over\-the\-counter medication within 1 week prior to the first administration of study drug, and this will affect this study or the safety of the subjects in the opinion of the investigator
- •8\) Participation in any other study within 3 months prior to the first administration of study drug (the completion date of previous study is the day of the last administration of study drug)
- •9\) Donation of whole blood within 2 months prior to the first administration of study drug, or donation of any blood component within 1 month prior to the first administration of study drug
- •10\) History of excessive alcohol abuse (\> 21units/week, 1 unit \= 10g \= 12\.5mL of pure alcohol), or subjects who cannot abstain from drinking during the study period, or excessive smoking (\> 10cigarettes/day)
Outcomes
Primary Outcomes
Not specified
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