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
| Registry | NCT06916169 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 70 (Estimated) |
| Sponsor | Ahn-Gook Pharmaceuticals Co.,Ltd (Industry) |
| Conditions | Pharmacokinetics |
| Interventions | AG2304, AG23041 and AG23042 (Drug) |
| Dates | start 2025-08-01 (estimated), primary completion 2025-09-01 (estimated), completion 2025-09-01 (estimated), first posted 2025-04-08, last updated 2025-04-08 |
Related Papers Related Patents Related Grants Related Experts
All trials for Pharmacokinetics All trials of AG2304 All trials of AG23041 and AG23042
The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sequence A | Experimental | Drug: AG2304; Drug: AG23041 and AG23042 | Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304 |
| Sequence B | Active comparator | Drug: AG2304; Drug: AG23041 and AG23042 | Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042 |
Sex: All, ages: 19 Years to 65 Years, 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