Status:
NOT_YET_RECRUITING
The Food Effect on PK Characteristics and Safety Profiles of PA-111
Lead Sponsor:
Addpharma Inc.
Conditions:
Mixed Dyslipidemia
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06976489
Start Date
May 1 2025
End Date
July 1 2025
Last Update
May 16 2025
Active Locations (1)
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1
H Plus Yangji Hospital
Seoul, South Korea