A study to evaluate the safety and pharmacokinetics of Bojungikgi-tang EX granules
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0002781
- Lead Sponsor
- Daegu Oriental Hospital of Daegu Haany University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 12
1) Age : 19 or/and above, 45 or/and below, healthy male participants.
2) Weight : 55kg or/and above, IBW : between ±20%
3) Those who had no congenital disease, no chronic disease and no other pathologic conditions.
4) Those who had normal range at blood chemistry, CBC and UA.
5) Those who provided written informed consent voluntarily, after completely understood about the study.
1) Those who have disease associated with liver, kidney, nerology, respiratory, oncology, urinary, psychiatric, cardiovascular, endocrine.
2) Those who have gastrointestinal disease that could cause malabsorption of the study drug.
3) Those who have an allergy to the study drug.
4) Those who have history of drug abuse
5) who had exessive drinking or took barbitalic drug 1 month before screening.
6) who took presciption-based medicine or herbal medicine 10 days before screening, or who took over the counter(OTC) drug or vitamins 1 week before screening
7) who participated other clinical study 3 months before screening
8) who donated blood 1 month before screening or who received transfusion 1 month before screening.
9) who drank consistently (more than 21 units/week , 1 unit = 10 g of pure alcohol) or who are not capable of stop drinking during the study.
10) inappropriate in this study confirmed by researchers
11) - Hemoglobin < 12.0 g/dL
- AST or ALT > 1.25 times of normal range
- Total bilirubin > 1.5 times of normal range
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax in Glycyrrhetic acid
- Secondary Outcome Measures
Name Time Method AUCinf, tmax, t1/2, CL/F in Glycyrrhetic acid