Healthy Adult
Conditions
Brief summary
This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects
Interventions
DRUGDA-5223(Fasting)
once a day
DRUGDA-5223(Fed)
once a day
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult male or female, 19 years to 55 years * Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 * The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate
Exclusion criteria
* The subjects with acute illness * The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product * The subjects hypersensitive to any of the Investigational Product components or other drug components * The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization * The subjects who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC-last | 0~12 hours | Area under the plasma concentration-time curve up to the last measurable concentration |
| Cmax | 0~12 hours | Peak Plasma Concentration |
Countries
South Korea
Outcome results
None listed