A study to evaluate the safety and pharmacokinetics of Bojungikgi-tang EX granules

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002781

Enrollment

Registered

2018-04-06

Start date

2018-01-03

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Amount per once : Bojungikgi-Tang EX granules 5g 3 times a day, total 4weeks (28days) oral intake

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
AUCt, Cmax in Glycyrrhetic acid	—

Secondary

Measure	Time frame
AUCinf, tmax, t1/2, CL/F in Glycyrrhetic acid	—

Countries

Korea, Republic of

Contacts

Public ContactMIN KWAK

Daegu Oriental Hospital of Daegu Haany University

nari003@hanmail.net+82-53-670-5756

Outcome results