Phase 1 Study to Evaluate the Safety and Drug-Drug Interactions in Healthy Adult Participants

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07797621

Enrollment

Registered

2026-09-01

Start date

2025-03-28

Completion date

2025-05-02

Last updated

2026-09-01

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

Conditions

Acute Bronchitis

Brief 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.

Interventions

DRUGAG2203L

Multiple doses of 1 tablet three times daily under fasting conditions, followed by a single dose of 1 tablet once daily under fasting conditions.

DRUGAG2203E

Multiple doses of 1 capsule three times daily under fasting conditions, followed by a single dose of 1 capsule once daily under fasting conditions.

DRUGAG2203L+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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Individuals aged 19 years or older at the time of screening. * Individuals with a body mass index (BMI) of 18-30 kg/m². * Individuals who are considered eligible for participation by the principal investigator based on the results of diagnostic tests and other screening assessments specified according to the characteristics of the investigational products.

Exclusion criteria

* Individuals who participated in a bioequivalence study or another clinical trial and received an investigational product within 30 days before the start of this study. * Individuals who consumed alcohol regularly within 1 month before the start of this study. * Individuals with a known hypersensitivity to either investigational product or any of its components.

Design outcomes

Primary

Measure	Time frame
AUCt,ss AG2203L and AG2203E	0~12 hours post-dose
Cmax,ss AG2203L and AG2203E	0~12 hours post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026