NCT06932705

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Addpharma Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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 evaluate the pharmacokinetic characteristics and safety profiles of PA-111 compared with coadministration PA-111A in healthy subjects.

Conditions

• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	PA-111	PA-111 1Tab., Per Oral
DRUG	PA-111A	PA-111A 1Capsule., Per Oral

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: South Korea