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To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects
A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026) |
|
| B | Experimental | Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I) |
|
| C | Experimental | Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II) |
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| D | Experimental | Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II) |
|
| E | Experimental | Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-382(formulation I) | Drug | 1 tablet administered under fasting condition for 7days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| MinKyu Park, Ph.D | Contact | 043-269-8708 | mk_park@cbnuhctc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Recruiting | Cheongju-si | North Chungcheong | 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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|
| F | Experimental | Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I) |
|
| CKD-382(formulation II) | Drug | 1 tablet administered under fasting condition for 7days |
|
| D026 | Drug | 1 tablet administered under fasting condition for 7days |
|
| D004066 | Digestive System Diseases |