NCT07007520 A Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
| NCT ID | NCT07007520 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dong-A ST Co., Ltd. |
| Condition | Healthy Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-11 |
| Primary Completion | 2025-11 |
Trial Parameters
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Brief Summary
This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects
Eligibility Criteria
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