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Not yet recruiting NCT06549504

Bioequivalence Study of AG2202

Phase I Interventional Bioequivalence Study

For patients and families

In plain language

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: AG2202T, AG2202R.
Who it may be relevant to
Registry conditions: Bioequivalence Study. Basic parameters: from 19 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 →

Unsure about the terms? Read our patient guide →

Official title

An Open-label, Randomized, Fasting, Single, Oral Administration, Group 2, Stage 2, Cross-over Bioequivalence Study of AG2202 in Healthy Volunteers

Overview

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.

Interventions

  • Drug AG2202T
    AG2202T Single-dose
  • Drug AG2202R
    AG2202R Single-dose

Primary outcome measures

  • AUC [Time frame: Pharmacokinetic plasma samples collected over 36 hour period]
  • Cmax [Time frame: Pharmacokinetic plasma samples collected over 36 hour period]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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: NCT06549504 · AG2202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗