NCT05259020 - To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers | Crick | Crick
To Evaluate the Pharmacokinetics and the Safety of ID14009 Compared to Coadministration of ID1805 With ID1803 in Healthy Adult Volunteers
(Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)
Eligibility
Sex: ALLMin age: 19 YearsHealthy volunteers:
Medical Language ↔ Plain English
Inclusion Criteria:
* Healthy adult volunteers aged over 19 years
* Subjects who have over 50kg and BMI more than 18.5kg/m\^2 and less than 29.9kg/m\^2
* Subjects who are eligible for this study as determined by clinical laboratory test results, urine test results, vital sign measurements, 12-lead ECG results, and physical examination findings during screening.
* Subjects must agree to practice a medically acceptable method of birth control and should not donate sperm or eggs until 28 days after last dose of study drug.
* Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period
Exclusion Criteria:
* • Subject with any clinically significant cardiovascular, respiratory, endocrinology, infectious disease, ophthalmology, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
* History of gastrointestinal disease (except for appendectomy or herniotomy) or surgery (ex. Crohn's disease, ulcer) that may affect the absorption of a given drug
* Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
* Subject with symptoms of acute disease within 28days prior to study medication dosing
* Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:
* Subject with a history of drug abuse or urinalysis positive
* Subject with clinically significant active chronic disease
* Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
* Genetic myopathic disorder or related family history
* Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab
* Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
* Subject who cannot take standard meal in hospitalization
* Present history of hypothyroidism or clinically significant assay
* Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
* Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.
* Subjects who judged ineligible by the investigator