RecruitingPhase 1NCT06932705
A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and the Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adult Volunteers Under Fed State Conditions
Sponsor
Addpharma Inc.
Enrollment
48 participants
Start Date
Apr 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of PA-111 in healthy subjects.
Eligibility
Min Age: 19 Years
Inclusion Criteria2
- 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 Criteria2
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
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Interventions
DRUGPA-111
PA-111 1Tab., Per Oral
DRUGPA-111A
PA-111A 1Capsule., Per Oral
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06932705
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