Status:
NOT_YET_RECRUITING
Bioequivalence Study of AG2202
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Bioequivalence Study
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06549504
Start Date
August 1 2024
End Date
September 1 2024
Last Update
August 14 2024
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