Dyslipidemias, Hypertension
Conditions
Brief summary
To evaluate the pharmacokinetics and the safety of ID14009 compared to coadministration of ID1805 with ID1803 in healthy adult volunteers.
Interventions
COMBINATION_PRODUCTID140009
Combination Product: ID140009 Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg/ Amlodipine 10mg/ Valsartan 160mg
COMBINATION_PRODUCTID1803+ID1805
(Amlodipine 10mg/Valsartan 160mg)+(Ezetibmibe 10mg/ Rosuvastatin Ca 20.8mg)
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCt (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) | 0~72hr | Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: AUCt |
| Cmax (Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine) | 0~72hr | Total Ezetimibe, Rosuvastatin, Valsartan, Amlodipine: Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCt (Free Ezetimibe) | 0~72hr | Free Ezetimibe: AUCt |
| Cmax (Free Ezetimibe) | 0~72hr | Free Ezetimib: Cmax |
Countries
South Korea
Contacts
Primary ContactMinJung Kim
Outcome results
None listed