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It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation.
To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement.
All subjects who received more than one dose of clinical trial drugs are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Test Drug for Period I Reference Drug for Period II |
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| Group 2 | Other | Reference Drug for Period I Test Drug for Period II |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference Drug or Test Drug | Drug | Test Drug: single administration of JW0301 Reference Drug: single administration of C2105 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„, 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 |
|---|---|---|
| SeungHwan Lee, PI | Clinical Trial Center, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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A randomized, open, single-dose, 2x2 crossover-design clinical trial
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