NCT07633691CompletedPhase 1
An Open-label, Randomized, Single-dose, Two-Cohort, Two-Period, Crossover Study to Exploratively Evaluate the Safety, Tolerability and Pharmacokinetics of DA-5223 Compared With DA-5223-R in Healthy Adult Subjects
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 12
- Locations
- 1
Study Overview
Brief Summary
This study will exploratively evaluate the safety, tolerability and pharmacokinetics of DA-5223 compared with DA-5223-R in healthy adult subjects
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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 1 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
- •The subjects who are pregnant or lactating
Arms & Interventions
Sequence D
Experimental
Intervention: DA-5223-R (Drug)
Sequence D
Experimental
Intervention: DA-5223-M (Drug)
Sequence C
Experimental
Intervention: DA-5223-R (Drug)
Sequence C
Experimental
Intervention: DA-5223-M (Drug)
Sequence A
Experimental
Intervention: DA-5223-R (Drug)
Sequence A
Experimental
Intervention: DA-5223-F (Drug)
Sequence B
Experimental
Intervention: DA-5223-R (Drug)
Sequence B
Experimental
Intervention: DA-5223-F (Drug)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 1
Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting StateNCT07297940Dong-A ST Co., Ltd.40
Completed
Phase 1
Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fed StateNCT07342062Dong-A ST Co., Ltd.36
Recruiting
Phase 1
Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers Under Fed Condition.NCT07267221Daewoong Pharmaceutical Co. LTD.36
Recruiting
Phase 1
A Study of TRC003 in the Treatment of Patients With Progressive PSMA-positive mCRPCProstate CancerNCT07567521C Ray Therapeutics90
Recruiting
Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)NCT07425522Genentech, Inc.93