Bioequivalence Study of AG2202
An Open-label, Randomized, Fasting, Single, Oral Administration, Group 2, Stage 2, Cross-over Bioequivalence Study of AG2202 in Healthy Volunteers
1 other identifier
interventional
34
0 countries
N/A
Brief Summary
The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2024
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedAugust 14, 2024
August 1, 2024
1 month
August 8, 2024
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
AUC
Area under the plasma concentration
Pharmacokinetic plasma samples collected over 36 hour period
Cmax
Peak Plasma Concentration
Pharmacokinetic plasma samples collected over 36 hour period
Study Arms (2)
AG2202T
EXPERIMENTALAG2202R
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 12, 2024
Study Start
August 1, 2024
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
August 14, 2024
Record last verified: 2024-08