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A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042 Phase 1 70

Not yet recruiting
Clinical Trial NCT06916169 is designed to study Treatment for Pharmacokinetics. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 1 August 2025 until the study accrues 70 participants. Led by Ahn-Gook Pharmaceuticals Co.,Ltd, this study is expected to complete by 1 September 2025. The latest data from ClinicalTrials.gov was last updated on 8 April 2025.
Brief Summary
The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.
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.
Official Title

An Open-label, Randomized, Fasting, Single, Group 2, Stage 2, Cross-over Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042 in Healthy Adult Volunteers

Conditions
Pharmacokinetics
Other Study IDs
  • AG2304 BE
NCT ID Number
NCT06916169
Start Date (Actual)
2025-08
Last Update Posted
2025-04-08
Completion Date (Estimated)
2025-09
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSequence A
Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304
AG2304
AG2304, Single-dose Oral Administration
AG23041 and AG23042
AG23041/AG23042, Single-dose Oral Administration
Active ComparatorSequence B
Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042
AG2304
AG2304, Single-dose Oral Administration
AG23041 and AG23042
AG23041/AG23042, Single-dose Oral Administration
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
AUC
Area under the plasma concentration
Pharmacokinetic plasma samples collected over a 72-hour period
Cmax
Peak Plasma Concentration
Pharmacokinetic plasma samples collected over a 72-hour period
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
19 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • A healthy adults aged 19-65 years at the time of screening
  • Subjects who are deemed eligible based on the screening tests

  • Subjects who have taken the investigational drug within 6 months prior to the first dose
  • Other exclusions have been applied
Ahn-Gook Pharmaceuticals Co.,Ltd logoAhn-Gook Pharmaceuticals Co.,Ltd
No contact data.