Healthy
Conditions
Brief summary
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers
Detailed description
The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers.
Interventions
DRUGDWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)
DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period)
DRUGSevikar and Crestor
Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject who provided written informed consent to participate in this study * Healthy adult male subjects aged 19 to 50 years * Subjects whose body weight ≥ 55 kg and Body Mass Index(BMI) ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 * Subject who was judged to be healthy and suitable for the participation by the investigator based on screening test results
Exclusion criteria
* Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs * Subjects who had a serious clinical illness that can impact fate of drugs absorption * Subject who shows vital signs with the number of systolic blood pressure of \>140 mmHg or \<100 mmHg, and the number of diastolic blood pressure of \>90mmHg or \<65mmHg * Subject who have experienced drug abuse * Subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) * Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | [ Time Frame: 0 - 72 hours ] | AUC |
| Cmax | [ Time Frame: 0 - 72 hours ] | Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vdss/F | [ Time Frame: 0 - 72 hours ] | Vdss/F |
| t1/2β | [ Time Frame: 0 - 72 hours ] | t1/2β |
| Tmax | [ Time Frame: 0 - 72 hours ] | Tmax |
| AUCinf | [ Time Frame: 0 - 72 hours ] | AUCinf |
| CL/F | [ Time Frame: 0 - 72 hours ] | CL/F |
Countries
South Korea
Outcome results
None listed