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Clinical Trials/KCT0008735
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

Sponsor
Koera University Guro Hospital

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