A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042

The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.

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Key information

Conditions

Pharmacokinetics

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

To evaluate the pharmacokinetic characteristics and safety profiles of AG2304 compared with coadministration AG23041 and AG23042 after a single oral dose administration in healthy Korean subjects under fasting conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A healthy adults aged 19-65 years at the time of screening
Subjects who are deemed eligible based on the screening tests

Exclusion criteria

Subjects who have taken the investigational drug within 6 months prior to the first dose
Other exclusions have been applied

Treatment and study plan

AG2304

Drug

AG2304, Single-dose Oral Administration

AG23041 and AG23042

Drug

AG23041/AG23042, Single-dose Oral Administration

Primary outcomes

AUC

Time frame: Pharmacokinetic plasma samples collected over a 72-hour period

Area under the plasma concentration
Cmax

Time frame: Pharmacokinetic plasma samples collected over a 72-hour period

Peak Plasma Concentration

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

An Open-label, Randomized, Fasting, Single, Group 2, Stage 2, Cross-over Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042 in Healthy Adult Volunteers

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 8, 2025
Registry last updated: Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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