None listed
Conditions
Interventions
Drug : Subjects will be randomly assigned to Group A or Group B, and the two groups will differ in the sequence of co-administration of Daesiho-tang and Hwangryunhaedok-tang. All study drugs will be a
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male volunteers aged 19 to 45 years, inclusive, at the time of providing informed consent 2) Subjects weighing at least 50 kg and having a body mass index (BMI) between 18.0 and 29.9 kg/m², inclusive ? BMI (kg/m²) = body weight (kg) / [height (m)]² 3) Subjects who, after receiving a detailed explanation of the clinical trial and fully understanding it, voluntarily decide to participate and provide written informed consent to comply with the study requirements and precautions 4) Subjects who are judged by the investigator to be healthy based on the screening assessments, including physical examination, clinical laboratory tests, and medical history interview
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of clinically significant hepatic, gastrointestinal, cardiovascular, renal, neurological, respiratory, endocrine, immune, hematologic, oncologic, or psychiatric disease, or a history of drug abuse 2) Subjects with a history of hypersensitivity to any investigational product or to drugs of the same class as the investigational products 3) Subjects who meet any contraindication specified in the approved labeling of the investigational products, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 4) Subjects with a history of gastrointestinal disease that may affect the absorption of the investigational products, such as Crohn’s disease, ulcer, or acute or chronic pancreatitis, or a history of gastrointestinal surgery, except for simple appendectomy or hernia repair 5) Subjects who meet any of the following criteria at screening: ? Subjects with a systolic blood pressure of = 150 mmHg or = 90 mmHg, or a diastolic blood pressure of = 100 mmHg or = 60 mmHg, measured in the seated position after resting for at least 3 minutes ? Subjects whose serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level is at least 1.5 times the upper limit of normal in clinical laboratory tests for the assessment of liver function ? Subjects whose serum creatinine level exceeds the reference range or whose estimated glomerular filtration rate (eGFR), calculated using the Modification of Diet in Renal Disease (MDRD) equation, is less than 60 mL/min/1.73 m² ? Subjects with a positive serologic test result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or rapid plasma reagin, or with a result exceeding the applicable reference range 6) Subjects who have used, or are unable to refrain from using, any of the following foods or medications during the periods specified below: ? Subjects who continuously used drugs or consumed foods known to induce or inhibit CYP enzymes within 4 weeks before the first administration ? Subjects who used any prescription drug or herbal medicinal product that may affect the characteristics of the investigational products within 2 weeks before the first administration, or any over-the-counter medication or vitamin preparation within 1 week before the first administration. However, subjects may participate in the clinical trial at the investigator’s discretion if the medication is considered not to affect the pharmacokinetic characteristics of the investigational products. ? Subjects who used drugs that induce or inhibit drug-metabolizing enzymes, such as barbiturates, within 1 month before the first administration, or used any medication that may interfere with the clinical trial within 10 days before the first administration ? Subjects who consumed grapefruit or grapefruit-containing foods or beverages within 72 hours before the first administration, or who are unable to refrain from consuming them until the end of the study ? Subjects who consumed caffeine or caffeine-containing foods or beverages within 72 hours before the first administration, or who are unable to refrain from consuming them until the end of the study ? Subjects who regularly consumed more than 21 units of alcohol per week within 6 months before the first administration, where 1 unit equals 10 g or 12.5 mL of pure alcohol, or who are unable to abstain from alcohol from the time of providing written informed consent until the end
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration and area under the concentration–time curve of rosuvastatin, ezetimibe, and fenofibrate;Concentration values of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessments (vital signs, physical examination, clinical laboratory tests, and adverse events) | — |
Countries
Korea, Republic of
Contacts
Public ContactBo-Hyung Kim
Kyung Hee University Hospital
Outcome results
None listed