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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06916169
Enrollment
70
Registered
2025-04-08
Start date
2025-08-31
Completion date
2025-09-30
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

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.

Interventions

DRUGAG2304

AG2304, Single-dose Oral Administration

DRUGAG23041 and AG23042

AG23041/AG23042, Single-dose Oral Administration

Sponsors

Ahn-Gook Pharmaceuticals Co.,Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
AUCPharmacokinetic plasma samples collected over a 72-hour periodArea under the plasma concentration
CmaxPharmacokinetic plasma samples collected over a 72-hour periodPeak Plasma Concentration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026