Bioequivalence StudyPhase 1NCT06549504
Bioequivalence Study of AG2202
A Phase 1 study testing AG2202T and AG2202R in people with Bioequivalence Study, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
Trial summary
The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- AG2202T and AG2202R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Sep 2024
- 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
- Subjects aged 19 years or older at the time of screening
- Subjects with a BMI of 18.0-30.0 kg/m2
- Subjects who do not have clinically significant congenital or chronic diseases and who do not have any pathological symptoms or findings as a result of general clinical examination
- Subjects who are deemed eligible based on the screening tests
Who cannot join
- Subjects who have taken drugs that induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose or who have taken drugs that may interfere with the investigational product within 10 days prior to the first dose
- Subjects who have taken the investigational drug within 6 months prior to the first dose
- Subjects who donated whole blood within 8 weeks prior to the first dose, or donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the first dose
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Randomized, Fasting, Single, Oral Administration, Group 2, Stage 2, Cross-over Bioequivalence Study of AG2202 in Healthy Volunteers
The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.
Read the detailed description
To evaluate the bioequivalence of two formulations of AG2202T and AG2202R after a single oral dose administration in healthy Korean subjects under fasting conditions.
- Conditions
- Bioequivalence Study
- Being tested
- AG2202T, AG2202R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG2202TDrug
AG2202T Single-dose
AG2202RDrug
AG2202R Single-dose
| Study group | Role | What they receive |
|---|---|---|
| AG2202T | Experimental | Not described Receives: Drug: AG2202T |
| AG2202R | Active comparator | Not described Receives: Drug: AG2202R |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the plasma concentration
Measured: Pharmacokinetic plasma samples collected over 36 hour period
Cmax
Peak Plasma Concentration
Measured: Pharmacokinetic plasma samples collected over 36 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies 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
- 34 participants (estimated)
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
- NCT06549504
- Sponsor's protocol ID
- AG2202
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single, Oral Administration, Group 2, Stage 2, Cross-over Bioequivalence Study of AG2202 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06549504
- Acronym / sponsor ID
- AG2202
- Conditions
- Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 12 Aug 2024 (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.
The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.
Detailed description
To evaluate the bioequivalence of two formulations of AG2202T and AG2202R after a single oral dose administration in healthy Korean subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AG2202T | Experimental | Drug: AG2202T |
| AG2202R | Active comparator | Drug: AG2202R |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 19 years or older at the time of screening
- Subjects with a BMI of 18.0-30.0 kg/m2
- Subjects who do not have clinically significant congenital or chronic diseases and who do not have any pathological symptoms or findings as a result of general clinical examination
- Subjects who are deemed eligible based on the screening tests
Key exclusion criteria (3 listed)
- Subjects who have taken drugs that induce or inhibit drug metabolizing enzymes within 30 days prior to the first dose or who have taken drugs that may interfere with the investigational product within 10 days prior to the first dose
- Subjects who have taken the investigational drug within 6 months prior to the first dose
- Subjects who donated whole blood within 8 weeks prior to the first dose, or donated blood components within 2 weeks, or received a blood transfusion within 4 weeks prior to the first dose
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 |
|---|---|---|
| AG2202TAG2202T Single-dose | Drug | AG2202T |
| AG2202RAG2202R Single-dose | Drug | AG2202R |
Primary outcome
AUC
Time frame: Pharmacokinetic plasma samples collected over 36 hour period
Area under the plasma concentration
Cmax
Time frame: Pharmacokinetic plasma samples collected over 36 hour period
Peak Plasma Concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
Related trials for Bioequivalence Study
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
Active, not recruitingPhase 1
Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions
Bioequivalence Study in Healthy Subjects, Immune Thrombocytopenia (ITP)
RecruitingPhase 1
Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients
Bioequivalence
Not yet recruitingPhase 1
Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
Bioequivalence
Not yet recruiting
Coffee Bioequivalence Trial
Liver Functions, Bioequivalence
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG2202T and AG2202R in people with Bioequivalence Study, run by Ahn-Gook Pharmaceuticals Co.,Ltd.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soyeon Jeong (+82-2-3289-4359, soyoun1628@ahn-gook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: Pharmacokinetic plasma samples collected over 36 hour period). 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 14 Aug 2024; AzTrials last refreshed its copy on 2 Nov 2026.