An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of PA-111 Compared to PA-111A in Healthy Adults Under Fed Conditions

What this Trial Is About

This research aims to evaluate and compare the pharmacokinetic characteristics and safety profiles of two drugs, PA-111 and PA-111A, in healthy adult volunteers. It focuses on understanding how these drugs behave in the body, including their maximum concentration in the blood and the total exposure over time. The study is conducted in a controlled fed state environment to ensure consistent conditions. Participants will receive both PA-111 and PA-111A in a randomized, open-label, crossover design. The study is divided into two periods: in one, participants take PA-111A first followed by PA-111, and in the other, they receive PA-111 first followed by PA-111A. Each drug is given as a single oral dose, with PA-111 provided as a tablet and PA-111A as a capsule. During the study, researchers will monitor drug levels in the blood from before dosing up to 72 hours afterward to measure key pharmacokinetic parameters. Safety assessments will also be conducted throughout. Participation involves multiple visits over a period that includes both dosing and monitoring. The study is planned to start in April 2025 and continue until May 2025, involving healthy adult volunteers meeting specific weight and body mass index requirements.

A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A