Bioequivalence Study
Conditions
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.
Interventions
DRUGAG2202T
AG2202T Single-dose
DRUGAG2202R
AG2202R Single-dose
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | Pharmacokinetic plasma samples collected over 36 hour period | Area under the plasma concentration |
| Cmax | Pharmacokinetic plasma samples collected over 36 hour period | Peak Plasma Concentration |
Contacts
Primary ContactSoyeon Jeong
Outcome results
None listed