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NCT Number: NCT06549504

Bioequivalence Study of AG2202

The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

To evaluate the bioequivalence of two formulations of AG2202T and AG2202R after a single oral dose administration in healthy Korean subjects under fasting conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AG2202T

Drug

AG2202T Single-dose

AG2202R

Drug

AG2202R Single-dose

Primary outcomes

  1. AUC

    Time frame: Pharmacokinetic plasma samples collected over 36 hour period

    Area under the plasma concentration

  2. Cmax

    Time frame: Pharmacokinetic plasma samples collected over 36 hour period

    Peak Plasma Concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Soyeon Jeong

CONTACT

[email protected]

+82-2-3289-4359

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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