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

Ahn-Gook Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: AG2304; Drug: AG23041 and AG23042

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916169

AG2304 BE

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304

Treatment:

Drug: AG23041 and AG23042

Drug: AG2304

Sequence B

Active Comparator group

Description:

Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042

Treatment:

Drug: AG23041 and AG23042

Drug: AG2304