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

Phase 1

Not yet recruiting

• Conditions: Pharmacokinetics
• Interventions: Drug: AG2304; Drug: AG23041 and AG23042

• Registration Number: NCT06916169
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-08
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	AG2304	Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304
Sequence A	AG23041 and AG23042	Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304
Sequence B	AG2304	Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042
Sequence B	AG23041 and AG23042	Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042

Primary Outcome Measures

Name	Time	Method
AUC	Pharmacokinetic plasma samples collected over a 72-hour period	Area under the plasma concentration
Cmax	Pharmacokinetic plasma samples collected over a 72-hour period	Peak Plasma Concentration