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Phase 1 Study to Evaluate the Safety and Drug-Drug Interactions in Healthy Adult Participants
Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Summary
This Phase 1 study will evaluate the safety and drug-drug interactions of AG2203L and AG2203E in healthy adult participants. Participants will receive AG2203L and AG2203E alone and in combination during three treatment periods according to one of six randomly assigned treatment sequences.
Official title: A Randomized, Open-Label, Oral, Multiple-Dose, Six-Sequence, Three-Period Crossover Phase 1 Clinical Trial to Evaluate the Safety and Drug-Drug Interactions of "AG2203L" and "AG2203E" in Healthy Adult Participants.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-03-28
Completion Date
2025-05-02
Last Updated
2026-09-01
Healthy Volunteers
Yes
Conditions
Interventions
AG2203L
Multiple doses of 1 tablet three times daily under fasting conditions, followed by a single dose of 1 tablet once daily under fasting conditions.
AG2203E
Multiple doses of 1 capsule three times daily under fasting conditions, followed by a single dose of 1 capsule once daily under fasting conditions.
AG2203L+AG2203E
Multiple doses of 1 tablet and 1 capsule co-administered three times daily under fasting conditions, followed by a single dose of 1 tablet and 1 capsule co-administered once daily under fasting conditions.
Locations (1)
Kyungpook National University Hospital
Daegu, South Korea