Bioequivalence Study of AG2202

Ahn-Gook Pharmaceuticals

Status and phase

Not yet enrolling

Phase 1

Conditions

Bioequivalence Study

Treatments

Drug: AG2202T

Drug: AG2202R

Study type

Interventional

Funder types

Industry

Identifiers

NCT06549504

AG2202

Details and patient eligibility

About

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

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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