Bioequivalence Study of AG2202

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-31

Study Completion Date

2024-09-30

Brief Summary

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

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Detailed Description

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

Conditions

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Bioequivalence Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AG2202T

Group Type EXPERIMENTAL

AG2202T

Intervention Type DRUG

AG2202T Single-dose

AG2202R

Group Type ACTIVE_COMPARATOR

AG2202R

Intervention Type DRUG

AG2202R Single-dose

Interventions

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AG2202T

AG2202T Single-dose

Intervention Type DRUG

AG2202R

AG2202R Single-dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes