A Clinical Trial to Compare the Safety, Tolerability, and PK Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216.

Study Overview
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Brief Summary
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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

Official Title
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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
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Healthy

Intervention / Treatment
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* Drug: DA-5216
* Drug: DA-5216-R
* Drug: DA-5216
* Drug: DA-5216


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [Part A] DA-5216<br> | Drug: DA-5216<br>* During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216-R(Fasting) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8. Sequence II. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216-R(Fasting) on Day 8.<br>|
| Experimental: [Part A] DA-5216-R<br> | Drug: DA-5216-R<br>* During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216-R(Fasting) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8. Sequence II. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216-R(Fasting) on Day 8.<br>|
| Experimental: [Part B] DA-5216(Fasting)<br> | Drug: DA-5216<br>* During the cross-over [Part B], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216(Fed) on Day 8. Sequence II. Single dose of DA-5216(Fed) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.<br>|
| Experimental: [Part B] DA-5216(Fed)<br> | Drug: DA-5216<br>* During the cross-over [Part B], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216(Fed) on Day 8. Sequence II. Single dose of DA-5216(Fed) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) PK parameter |  | 0 48hours | 
| Area under the plasma concentration versus time curve (AUClast) PK parameter |  | 0 48hours |