KCT0004056
Not yet recruiting
未知
Pharmacokinetics Research Phase I Phase 1 Researcher Clinical Trials (Peony root extract)
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- CHA University
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Healthy male Korean subject age 20 to 55 at the screening visit
- •2\)Subject who is over 55kg and As a result of calculated Ideal Body Weight, subject who is within the range of ±20%
- •\* IBW (kg) \= {height(cm) \- 100} \* 0\.9
- •3\)Physical examination was performed on the basis of this protocol, a subject who has been determined to be suitable to the subject of clinical trials via the interview. That is, subject who does not have congenital or chronic disease and as a result of medical examination(if necessary,EEG,chest and upper gastrointestinal endoscopy or radiography), subject who is no pathological symptoms or findings
- •4\)A person who is determined to be eligible for clinical trial as a result of a clinical pathology test, such as blood pathology test, blood chemistry test, urine test, etc.,
- •5\)After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice
- •6\)Patients with a previous history of hypertension, no history of antihypertensive medication, and those with a systolic blood pressure \<140 mmHg and a diastolic blood pressure \<90 mmHg in vital signs measured from the left after a rest of more than 3 minutes as measured in the main body
Exclusion Criteria
- •1\)A person who has taken liver, kidneys, nervous system, immune system, respiratory, musculoskeletal disease or blood available and the endocrine system and cancer diseases, cardiovascular diseases, mental disorders (mood disorders, obsessive compulsive disorder, etc.) who have a history or are(In the case of liver disease item, or hepatitis B antigen, including one who shows a hepatitis C antibody positive).
- •In particular,A person who has galactose intolerance, Lapp lactase deficiency or glucose\-galactose malabsorption.
- •2\)A person who has taken gastrointestinal diseases (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) and a history of gastrointestinal surgery (where the simple appendectomy or hernia operation is excluded)
- •3\)A person who had some lab data below.
- •After the break in the sitting position measured vital signs,systolic blood pressure \= 140mmHg or diastolic blood pressure \=90mmHg
- •4\)A person who has taken alcohol more than 30g/day or someone who can't stop drinking from 24hours before enrollment to discharging from hospital.
- •5\)A person who has taken xanthine continuously (coffee, tea, cola more than 4 cups per a day)
- •6\)A person who smoked more than 20 piece of tobacco/day or less, but can't stop smoking from on the day of blood collection period and during medication.
- •7\))A person who had enrolled to barbiturate's drugs by induction and inhibition of drug\-metabolizing enzymes of drugs, such as drugs or excessive drinking within the last 30 days.
- •8\)A person who has medical history of drug abuse or misuse (Amphetamine,barbiturates, cocaine, opioids, benzodiazepines, etc.)
Outcomes
Primary Outcomes
Not specified
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