Mixed Dyslipidemia
Conditions
Brief summary
This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.
Interventions
DRUGDW5124
DW5124 on fasted or fed condition
DRUGDW5124-R
DW5124-R on fasted or fed condition
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Volunteers who are ≥19 years and \>65 years old * Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2
Exclusion criteria
* Clinically significant Medical History * In the case of women, pregnant(Urine-HCG positive) or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | up to 72 hour | Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed |
| Area under the plasma concentration versus time curve (AUC) | up to 72 hour | Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | up to 72 hour | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed |
| Terminal half life (t1/2) | up to 72 hour | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed |
| Apparent clearance (CL/F) | up to 72 hour | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed |
| Apparent volume of distribution (Vd/F) | up to 72 hour | Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed |
Countries
South Korea
Outcome results
None listed