DP-R212 Pharmacokinetic Study Phase I
- Registration Number
- NCT02814500
- Lead Sponsor
- Alvogen Korea
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A group DP-R212 Amlodipine and Rosuvastatin, DP-R212 B group DP-R212 DP-R212, Amlodipine and Rosuvastatin B group Amlodipine DP-R212, Amlodipine and Rosuvastatin A group Amlodipine Amlodipine and Rosuvastatin, DP-R212 A group Rosuvastatin Amlodipine and Rosuvastatin, DP-R212 B group Rosuvastatin DP-R212, Amlodipine and Rosuvastatin
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method