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Completed

NCT Number: NCT07797621

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

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.

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Key information

Conditions

Acute Bronchitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. AUCt,ss AG2203L and AG2203E

    Time frame: 0~12 hours post-dose

  2. Cmax,ss AG2203L and AG2203E

    Time frame: 0~12 hours post-dose

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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