A clinical trial to evaluate the effect of Banhabaekchulcheonmatang and Hwangryeonhaedoktang on the pharmacokinetics of atorvastatin in healthy adults
- Conditions
- Not Applicable
- Registration Number
- KCT0008735
- Lead Sponsor
- Koera University Guro Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 14
1) Adults aged 19 to 50 years of age (inclusive) at the time of screening
2) Subjects with BMI of 18 to 32 kg/m2 (inclusive)
3) Subjects who agree to use medically acceptable methods of contraception and not to donate sperm or oocyte
4) Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
1) Subjects with current or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease
2) Subjects with current or history of clinically significant hypersensitivity reactions or hypersensitivity reactions to the components or constituents of the investigational product
3) Subjects with current or history of clinically significant myopathy, or a history or family history of inherited muscular disorders
4) Subjects with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
5) Subjects whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at screening
6) Subjects whose AST or ALT levels are more than 2 times the upper limit of normal range, or total bilirubin levels are more than 1.5 times the upper limit of normal range at screening
7) Subjects who have taken the following medication or medication known to have significant drug interactions with the investigational product within the 2 weeks prior to the first administration day
A.Strong CYP3A4 inhibitor or inducer
B. Inhibitors of OATP1B1 or P-gp
C. Herbal medicine, Korean traditional medicine, or supplements that contains the ingredients of Banhabaekchulcheonmatang or Hwangryeonhaedoktang
8) Subjects who donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration day
9) Subjects who participated and have been exposed to an investigational product in other clinical study within 180 days prior to the first administration day
10) Subjects who consistently consumed alcohol (alcohol > 21 units/week [1 unit = 10 mL of pure alcohol]) within 2 weeks of the first administration day
11) Pregnant or breastfeeding women
12) Subjects judged unsuitable to participate in the clinical study by investigators due to other reasons, including the results of laboratory tests
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUClast, AUCinf, Tmax, t1/2 of atorvastatin and its metabolites (2-OH atorvastatin, etc.)
- Secondary Outcome Measures
Name Time Method Safety: clinical laboratory tests