Hyperlipidemias, Hypertension
Conditions
Brief summary
To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
Detailed description
The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor 10mg in healthy male volunteers.
Interventions
DRUGCJ-30060
Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg
DRUGExforge tab 5/160mg, Crestor tab 10mg
Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male aged 20 to 45 years at the screening * Subject who is over 50kg with BMI between 18 kg/m2 to 29 kg/m2 (inclusive) * Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.
Exclusion criteria
* Subject who has a medical history of severe cardiovascular, respiratory, hepatobiliary, renal disease hematologic, gastrointestinal, endocrinological, immunologic, dermatosis or neuropsychologic disease. * Subject who have symptoms, result from acute disease within 28days before first administration. * Subject who have chronic persisting disease with clinical significance. * Subject who fall under the criteria below in laboratory test. * AST/ALT \> UNL (upper normal limit) x 2 * Total bilirubin \> UNL x 1.5 * In case of renal failure that creatine clearance is less than 50mL/min according to Cockcroft-Gault * CPK \> UNL x 2.5 * Subject who with low blood pressure with clinical significance at screening test. (systolic blood pressure is less than 90 mmHg and diastolic blood pressure is less than 60 mmHg) * Subject with any positive reaction in HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) of amlodipine, valsartan, rosuvastatin | Up to 144 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) of amlodipine, valsartan, rosuvastatin | Up to 144 hours post-dose |
| Time of maximum observed concentration (Tmax) of amlodipine, valsartan, rosuvastatin | Up to 144 hours post-dose |
| Half life (t1/2) of amlodipine, valsartan, rosuvastatin | Up to 144 hours post-dose |
| Oral clearance (CL/F) of amlodipine, valsartan, rosuvastatin | Up to 144 hours post-dose |
| Apparent volume of distribution (Vd/F) of amlodipine, valsartan, rosuvastatin | Up to 144 hours post-dose |
Countries
South Korea
Outcome results
None listed