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

NCT07797621 | Completed Phase 1

• 1 other identifier: AG2203_DDI
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (2)

• AUCt,ss AG2203L and AG2203E

  0~12 hours post-dose

• Cmax,ss AG2203L and AG2203E

  0~12 hours post-dose

Study Arms (6)

Sequence 1

EXPERIMENTAL

AG2203L+AG2203E in Period 1, AG2203L in Period 2, and AG2203E in Period 3.

Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E

Sequence 2

EXPERIMENTAL

AG2203E in Period 1, AG2203L+AG2203L in Period 2, and AG2203L in Period 3.

Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E

Sequence 3

EXPERIMENTAL

AG2203E in Period 1, AG2203L in Period 2, and AG2203E +AG2203L in Period 3.

Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E

Sequence 4

EXPERIMENTAL

AG2203L in Period 1, AG2203E in Period 2, and AG2203E +AG2203L in Period 3.

Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E

Sequence 5

EXPERIMENTAL

AG2203L in Period 1, AG2203E +AG2203L in Period 2, and AG2203E in Period 3.

Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E

Sequence 6

EXPERIMENTAL

AG2203E +AG2203L in Period 1, AG2203E in Period 2, and AG2203L in Period 3.

Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E

Interventions

AG2203L+AG2203E DRUG

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.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

AG2203L DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

AG2203E DRUG

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

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

Kyungpook National University Hospital

Daegu, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 1, 2026
• Study Start: March 28, 2025
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)