ClinicalTrials.gg
Not yet recruitingNCT06916169Updated Apr 8, 2025

A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042

A Phase 1 interventional study of AG2304 and AG23041 and AG23042 in Pharmacokinetics, sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. Not yet recruiting. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-08.

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

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.

Read the detailed description

To evaluate the pharmacokinetic characteristics and safety profiles of AG2304 compared with coadministration AG23041 and AG23042 after a single oral dose administration in healthy Korean subjects under fasting conditions.

02

Conditions studied

  • Pharmacokinetics
03

In context

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 to 65 Years
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

  • A healthy adults aged 19-65 years at the time of screening
  • Subjects who are deemed eligible based on the screening tests

Exclusion criteria

Exclusion Criteria:

  • Subjects who have taken the drug within 6 months prior to the first dose
  • Other exclusions have been applied
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

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

Study arms

  • Experimental
    Sequence A

    Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304

    Drug: AG2304 · Drug: AG23041 and AG23042

  • Active comparator
    Sequence B

    Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042

    Drug: AG2304 · Drug: AG23041 and AG23042

Interventions

  • DrugAG2304

    AG2304, Single-dose Oral Administration

  • DrugAG23041 and AG23042

    AG23041/AG23042, Single-dose Oral Administration

06

What researchers measure

Primary outcomes

  1. AUC

    Area under the plasma concentration

    Time frame: Pharmacokinetic plasma samples collected over a 72-hour period

  2. Cmax

    Peak Plasma Concentration

    Time frame: Pharmacokinetic plasma samples collected over a 72-hour period

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2025; primary completion for Sep 2025, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2025
First posted
Apr 8, 2025
StartEst.
Aug 2025
Primary completionEst.
Sep 2025
CompletionEst.
Sep 2025
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06916169
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Aug 2025 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Apr 8, 2025

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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