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Not yet recruiting NCT06916169

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

Phase I Interventional Pharmacokinetics

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AG2304, AG23041 and AG23042.
Who it may be relevant to
Registry conditions: Pharmacokinetics. Basic parameters: 19 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug AG2304
    AG2304, Single-dose Oral Administration
  • Drug AG23041 and AG23042
    AG23041/AG23042, Single-dose Oral Administration

Primary outcome measures

  • AUC [Time frame: Pharmacokinetic plasma samples collected over a 72-hour period]
  • Cmax [Time frame: Pharmacokinetic plasma samples collected over a 72-hour period]

Eligibility criteria

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

  • Subjects who have taken the investigational drug within 6 months prior to the first dose
  • Other exclusions have been applied

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06916169 · AG2304 BE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗