Clinical Trials for Pharmacological Standardization of Herbal Preparatio
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0000813
- Lead Sponsor
- Jeollanamdo Development Institute of Korean Traditional Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 100
In spite of being over weight over 55kg of weight within a range of ± 20% on the corresponding
- No congenital or chronic diseases, internal medicine, including an electrocardiogram findings jeokin examination results or who does not have psychotic symptoms.
- Doctor of medicine, depending on the characteristics set, conducted blood pathology, blood chemistry tests, urine tests, including clinical pathology in subjects who have been determined to be suitable.
- Clinically significant liver, kidney, nervous system, immune system, respiratory, musculoskeletal, endocrine, etc. to the disease or the blood, tumor diseases, cardiovascular diseases, mental illness, or who have a history.
- Testing of drugs that may affect the absorption of gastrointestinal disease or who have a history of gastrointestinal surgery.
- More than three minutes after the break loci in the measured vital signs = 160mmHg systolic blood pressure = 90mmHg or = 100mmHg or diastolic blood pressure = 60mmHg or equivalent to the carriers.
- Now more than usual, or 30g/day alcohol alcohol consumption during the week clinical trial who are not able to.
- Xanthine (coffee, tea, cola) beverages containing 4cup / day more than those who consume.
- Smoking more than 20 cigarettes a day cigarette or its smoke under, but who can not stop smoking, medication and blood sampling period.
- Drug clinical trial within 30 days of the first dose of barbital kinds of drugs, such as drug metabolism, enzyme induction and inhibition of drug taking and excessive drinking, and characters.
- A history of drug abuse or misuse interview and physical examination on the person concerned is suspected drugs.
- Drug clinical trial within 90 days before the first dose bioequivalence studies other or other parties who have participated in clinical trials.
- Chonnam National University Hospital provides a standard meal in the party that can not be.
- Clinical laboratory test results due to other reasons, including participation in clinical trials tester who deems inappropriate.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measured at each sampling time with the concentration of the blood plasma concentration-time area under the curve, ;maximum plasma concentratime ;time to reach maximum plasma concentration; elimination velocity constant;elimination half life.
- Secondary Outcome Measures
Name Time Method