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A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06932705•Addpharma Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 Criteria

•Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
•Other exclusions applied

Locations (1)

H Plus Yangji Hospital

Seoul, South Korea

Key Dates

Start Date

April 1, 2025

Primary Completion Date

May 1, 2025

Completion Date

May 1, 2025

Last Updated

April 17, 2025

Enrollment

ESTIMATED participants

Conditions

Mixed Dyslipidemia

Interventions

PA-111

DRUG

PA-111A

DRUG

Contacts

JeongEun Park

CONTACT

+82-31-891-6989 parkje@addpharma.co.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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