Healthy
Conditions
Brief summary
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212
Detailed description
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers
Interventions
DRUGDP-R212
Investigational product is prescribed to all of randomized subjects
DRUGAmlodipine
Investigational product is prescribed to all of randomized subjects
DRUGRosuvastatin
Investigational product is prescribed to all of randomized subjects
Sponsors
Alvogen Korea
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 17.5\ 30.5 * 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 30 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 |
|---|---|
| AUClast | 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr |
| Cmax | 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr |
Contacts
Primary ContactMin-Geol Kim, M.D
Outcome results
None listed