DP-R208 Pharmacokinetic Study
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02709187
- 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-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 37
Inclusion Criteria
- BMI 18~30
- 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 RT group DP-R208 combination dose of Candesartan and Rosuvastatin and DP-R208 in order RT group Rosuvastatin combination dose of Candesartan and Rosuvastatin and DP-R208 in order TR group DP-R208 DP-R208 and combination dose of Candesartan and Rosuvastatin in order RT group Candesartan cilexetil combination dose of Candesartan and Rosuvastatin and DP-R208 in order TR group Candesartan cilexetil DP-R208 and combination dose of Candesartan and Rosuvastatin in order TR group Rosuvastatin DP-R208 and combination dose of Candesartan and Rosuvastatin in order
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) up to 48 hours post dose Peak Plasma Concentration (Cmax) up to 48 hours post dose
- Secondary Outcome Measures
Name Time Method