Dyslipidemias, Hypertension
Conditions
Brief summary
This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.
Detailed description
An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects
Interventions
COMBINATION_PRODUCTID1803
Amlodipine 10mg/Valsartan 160mg
COMBINATION_PRODUCTID1801
Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
COMBINATION_PRODUCTID1803+ID1801
Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male volunteers aged 19 to 45 years * Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2 * Males must be agree to practice a medically acceptable method\* of birth control and will not donate sperm during the study. * 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 serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease * Subject with symptoms of acute disease within 28days prior to study medication dosing * Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug * 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 |
|---|---|---|
| AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe) | 0~72hours | Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ |
| Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe) | 0~72hours | Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | 0~72hours | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Cmin,ss |
| Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | 0~72hours | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Tmax,ss |
| t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | 0~72hours | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: t1/2 |
| AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss | 0~72hours | N-desmethyl rosuvastatin, total ezetimibe: AUCτ |
| Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | 0~72hours | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: Vd/F |
| PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | 0~72hours | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: PTF |
| CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe) | 0~72hours | amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe: CLss/F |
| Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss | 0~72hours | N-desmethyl rosuvastatin, total ezetimibe: Cmax,ss |
Outcome results
None listed