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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Part A] DA-5216 | Experimental |
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| [Part A] DA-5216-R | Experimental |
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| [Part B] DA-5216(Fasting) | Experimental |
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| [Part B] DA-5216(Fed) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-5216 | Drug | During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences:
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| 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 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Hwan Lee, PhD | Contact | 02-2072-2343 | leejh413@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Seung Hwan Lee, PhD | SNUH Clinical Pharmacololgy and Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Soeul | South Korea |
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| DA-5216-R | Drug | During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences:
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| DA-5216 | Drug | During the cross-over [Part B], patients will be randomly assigned to receive one of the following treatment sequences:
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| DA-5216 | Drug | During the cross-over [Part B], patients will be randomly assigned to receive one of the following treatment sequences:
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