Mixed Dyslipidemia
Conditions
Brief summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
Detailed description
The purpose of this study is to compare and evaluate the effect of food on the safety and pharmacokinetic profiles of PA-111 in healthy adult subjects.
Interventions
DRUGPA-111
PA-111 1Tab., Per Oral
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
Exclusion criteria
* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * Other exclusions applied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum concentration of drug in plasma (Cmax) | pre-dose (0hour) to 72hours | Cmax of PA-111 |
| Area under the plasma concentration-time curve during dosing interval (AUCt) | pre-dose (0hour) to 72hours | AUCt of PA-111 |
Countries
South Korea
Contacts
Primary ContactJeongEun Park
Outcome results
None listed