Clinical Trial to Compare the Pharmacokinetics of DP-R208
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02707224
- Lead Sponsor
- Alvogen Korea
- Brief Summary
A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A DP-R208 combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order Group B DP-R208 DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order Group A Rosuvastatin combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order Group A Candesartan cilexetil combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order Group B Candesartan cilexetil DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order Group B Rosuvastatin DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) up to 72 hours post dose Area under the plasma concentration versus time curve (AUC) up to 72 hours post dose
- Secondary Outcome Measures
Name Time Method