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)

H Plus Yangji Hospital

Seoul, South Korea

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NCT06932705


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