NCT05506007UnknownPhase 1
A Randomized, Open-label, Single Dose, Cross-over Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetic Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216 in Healthy Adult Subjects.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUClast) PK parameter
Study Overview
Brief Summary
This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 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 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female volunteer 19 years to 50 years
- •Body weight in the range of 50.0kg and body mass index in the range of 18 to 27kg/m2
- •Subject who are negative in pregnancy test or pregnant or Lactating women
- •The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
- •The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire
Exclusion Criteria
- •Subject with serious active hepatobiliary, respiratory, digestive, hematologic, endocrine(diabetes mellitus, aldosteronism), immunologic, cardiovascular(hypertension, angina, heart failure, myocardial infarction, etc.), neurologic, urologic, otorhinolaryngologic, musculoskeletal, psychological disease or history of such disease
- •Subject with gastrointestinal disease (Crohn's disease, peptic ulcer, acute or chronic pancreatitis, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery).
- •Subject who have galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
- •Subject who have had one or more of the following findings
- •AST, ALT > 1.5 times the upper limit
- •CPK > 2.5 times the upper limit
- •eGFR <60mL/min/1.73m2
Arms & Interventions
[Part A] DA-5216
Experimental
Intervention: DA-5216 (Drug)
[Part A] DA-5216-R
Experimental
Intervention: DA-5216-R (Drug)
[Part B] DA-5216(Fasting)
Experimental
Intervention: DA-5216 (Drug)
[Part B] DA-5216(Fed)
Experimental
Intervention: DA-5216 (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUClast) PK parameter
Time Frame: 0~48hours
Peak Plasma Concentration (Cmax) PK parameter
Time Frame: 0~48hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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