Bioequivalence Study of AG2202
ConditionBioequivalence Study
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorAhn-Gook Pharmaceuticals Co.,Ltd
About this trial
The objective of this study is to evaluate the human bioequivalence of AG2202T and AG2202R.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
AG2202T
DrugAG2202T Single-dose
AG2202R
DrugAG2202R Single-dose
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: AG2202TExperimental treatment 1 intervention
Group B: AG2202RActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
AUC
Area under the plasma concentration
Time frame
Pharmacokinetic plasma samples collected over 36 hour period2
Cmax
Peak Plasma Concentration
Time frame
Pharmacokinetic plasma samples collected over 36 hour periodLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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