The Food Effect on PK Characteristics and Safety Profiles of PA-111
Phase 1
Not yet recruiting
- Conditions
- Mixed Dyslipidemia
- Interventions
- Drug: PA-111
- Registration Number
- NCT06976489
- Lead Sponsor
- Addpharma Inc.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A PA-111 Period 1: Fasted, Period 2: Fed Sequence B PA-111 Period 1: Fed, Period 2: Fasted
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H Plus Yangji Hospital
🇰🇷Seoul, Korea, Republic of