Hyperlipidemias, Hypertension
Conditions
Brief summary
An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.
Interventions
DRUGAmlodipine
Amlodipine administration
DRUGRosuvastatin
Rosuvastatin administration
Sponsors
Alvogen Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 18-29 * signed the informed consent form prior to the study participation
Exclusion criteria
* Clinically significant disease * Previously donate whole blood within 60 days or component blood within 14 days * Clinically significant allergic disease * Taken IP in other trial within 90 days * An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCτ,ss of Amlodipine and Rosuvastatin | 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr |
| Cmax,ss of Amlodipine and Rosuvastatin | 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr |
Countries
South Korea
Contacts
Primary ContactChul woo Kim, Ph.D.
Outcome results
None listed