Acute BronchitisPhase 1NCT07797621
Phase 1 Study to Evaluate the Safety and Drug-Drug Interactions in Healthy Adult Participants
A Phase 1 study testing AG2203L, AG2203E and AG2203L+AG2203E in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Bronchitis
- What is being tested?
- AG2203L, AG2203E and AG2203L+AG2203E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2025to 2 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- AG2203L, AG2203E, AG2203L+AG2203E
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG2203LDrug
Multiple doses of 1 tablet three times daily under fasting conditions, followed by a single dose of 1 tablet once daily under fasting conditions.
AG2203EDrug
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+AG2203EDrug
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 group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | AG2203L+AG2203E in Period 1, AG2203L in Period 2, and AG2203E in Period 3. Receives: Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E |
| Sequence 2 | Experimental | AG2203E in Period 1, AG2203L+AG2203L in Period 2, and AG2203L in Period 3. Receives: Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E |
| Sequence 3 | Experimental | AG2203E in Period 1, AG2203L in Period 2, and AG2203E +AG2203L in Period 3. Receives: Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E |
| Sequence 4 | Experimental | AG2203L in Period 1, AG2203E in Period 2, and AG2203E +AG2203L in Period 3. Receives: Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E |
| Sequence 5 | Experimental | AG2203L in Period 1, AG2203E +AG2203L in Period 2, and AG2203E in Period 3. Receives: Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E |
| Sequence 6 | Experimental | AG2203E +AG2203L in Period 1, AG2203E in Period 2, and AG2203L in Period 3. Receives: Drug: AG2203L; Drug: AG2203E; Drug: AG2203L+AG2203E |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt,ss AG2203L and AG2203E
Measured: 0~12 hours post-dose
Cmax,ss AG2203L and AG2203E
Measured: 0~12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start28 Mar 2025
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797621
- Sponsor's protocol ID
- AG2203_DDI
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07797621
- Acronym / sponsor ID
- AG2203_DDI
- Conditions
- Acute Bronchitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: AG2203L, Drug: AG2203E, Drug: AG2203L+AG2203EAG2203L+AG2203E in Period 1, AG2203L in Period 2, and AG2203E in Period 3. |
| Sequence 2 | Experimental | Drug: AG2203L, Drug: AG2203E, Drug: AG2203L+AG2203EAG2203E in Period 1, AG2203L+AG2203L in Period 2, and AG2203L in Period 3. |
| Sequence 3 | Experimental | Drug: AG2203L, Drug: AG2203E, Drug: AG2203L+AG2203EAG2203E in Period 1, AG2203L in Period 2, and AG2203E +AG2203L in Period 3. |
| Sequence 4 | Experimental | Drug: AG2203L, Drug: AG2203E, Drug: AG2203L+AG2203EAG2203L in Period 1, AG2203E in Period 2, and AG2203E +AG2203L in Period 3. |
| Sequence 5 | Experimental | Drug: AG2203L, Drug: AG2203E, Drug: AG2203L+AG2203EAG2203L in Period 1, AG2203E +AG2203L in Period 2, and AG2203E in Period 3. |
| Sequence 6 | Experimental | Drug: AG2203L, Drug: AG2203E, Drug: AG2203L+AG2203EAG2203E +AG2203L in Period 1, AG2203E in Period 2, and AG2203L in Period 3. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG2203LMultiple doses of 1 tablet three times daily under fasting conditions, followed by a single dose of 1 tablet once daily under fasting conditions. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| AG2203EMultiple doses of 1 capsule three times daily under fasting conditions, followed by a single dose of 1 capsule once daily under fasting conditions. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| AG2203L+AG2203EMultiple 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. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
AUCt,ss AG2203L and AG2203E
Time frame: 0~12 hours post-dose
Cmax,ss AG2203L and AG2203E
Time frame: 0~12 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG2203L, AG2203E and AG2203L+AG2203E in people with Acute Bronchitis, run by Ahn-Gook Pharmaceuticals Co.,Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt,ss AG2203L and AG2203E (time frame: 0~12 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.