ClinicalTrials.gg
CompletedNCT07797621Updated Sep 1, 2026

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

A Phase 1 interventional study of AG2203L and AG2203E in Acute Bronchitis, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Mar 2025, registered Aug 2026).
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Bronchitis

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03

In context

Bronchitis

156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.

This study's enrollment of 36 is below the median of 185 across 105 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 19 years or older at the time of screening.
  • Individuals with a (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 products.

Exclusion criteria

Exclusion Criteria:

  • Individuals who participated in a bioequivalence study or another clinical trial and received an 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 to either investigational product or any of its components.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Sequence 1

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

    Drug: AG2203L · Drug: AG2203E · Drug: AG2203L+AG2203E

  • Experimental
    Sequence 2

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

    Drug: AG2203L · Drug: AG2203E · Drug: AG2203L+AG2203E

  • Experimental
    Sequence 3

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

    Drug: AG2203L · Drug: AG2203E · Drug: AG2203L+AG2203E

  • Experimental
    Sequence 4

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

    Drug: AG2203L · Drug: AG2203E · Drug: AG2203L+AG2203E

  • Experimental
    Sequence 5

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

    Drug: AG2203L · Drug: AG2203E · Drug: AG2203L+AG2203E

  • Experimental
    Sequence 6

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

    Drug: AG2203L · Drug: AG2203E · Drug: AG2203L+AG2203E

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.

06

What researchers measure

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

07

Study locations

1 site
  • Kyungpook National University Hospital
    Daegu, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07797621
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Mar 28, 2025
Primary completion
May 2, 2025
Completion
May 2, 2025
Last update
Sep 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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