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
Interventions
DRUGDWJ1351
DRUGCo-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 * Subject who provided written informed consent to participate in this study
Exclusion criteria
* Subject who had a severe allergy or allergic reactions to the amlodipine, olmesartan, rosuvastatin or related drugs * Subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, digestive system, reproductive system, neurology, psychology, ophthalmic and skin disease * 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 ≥150 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥100mmHg or ≤66mmHg * 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 |
|---|---|
| AUC | 0 - 144 hr |
| Cmax | 0 - 144 hr |
Contacts
Primary ContactSang-Joon Kim
Outcome results
None listed