An open-label and single and repeated dosing study to evaluate the safety and pharmacokinetics of Bojungikgi-Tang EX granules in healthy volunteers

Daegu Oriental Hospital of Daegu Haany University0 个研究点目标入组 12 人开始时间: 待定最近更新: 2019年3月11日

研究概览

暂无简介。

•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

发起方

Daegu Oriental Hospital of Daegu Haany University