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A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR group | Experimental | Period 1: Test drug(CKD-381) Period 2: Reference drug(D026) |
|
| RT group | Experimental | Period 1: Reference drug(D026) Period 2: Test drug(CKD-381) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-381 | Drug | 1 tablet administered before the breakfast during 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) | Evaluation PK for Esomeprazole after multiple dose | 0~24h |
| Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose | Evaluation PD for ambulatory 24hr pH monitor | Baseline versus Multiple dose during 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung Sang Yu, M.D., Ph.D. | Department of Clinical Pharmacology and Therapeutics, Seoul Nat'l University College of Medicine and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Nat'l University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D026 |
| Drug |
1 tablet administered before the breakfast during 7 days |
|
| D004066 | Digestive System Diseases |