KCT0008735CompletedUnknown
A clinical trial to evaluate the effect of Banhabaekchulcheonmatang and Hwangryeonhaedoktang on the pharmacokinetics of atorvastatin in healthy adults
Koera University Guro Hospital0 sites14 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19(Year) to 50(Year) (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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