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A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 to AD-2141 in healthy volunteers.
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 compared with administration of AD-2141 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-T | Active Comparator | Period 1 : Test Drug(AD-214) Period 2 : Reference Drug(AD-2141) |
|
| T-R | Active Comparator | Period 1 : Reference Drug(AD-2141) Period 2 : Test Drug(AD-214) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-214 | Drug | 1 tablet administered before the breakfast during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss(Area under the plasma drug concentration-time curve) | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Gastric acidity(After 7days of repeated administration, The change of integrated gastric acidity) | Evaluation PD Rabeprazole after multiple dose | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau(Area under the plasma drug concentration-time curve) | Evaluation PK Rabeprazole after single dose | Day1 |
| Cmax(Maximum concentration of drug in plasma) | Evaluation PK Rabeprazole after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seunghwan Lee, M.D.,Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National 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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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| AD-2141 | Drug | 1 tablet administered before the breakfast during 7 days |
|
|
| Day1 |
| Tmax(Time to maximum plasma concentration) | Evaluation PK Rabeprazole after single dose | Day1 |
| t1/2(Terminal elimination half-life) | Evaluation PK Rabeprazole after single dose | Day1 |
| CL/F(Apparent clearance) | Evaluation PK Rabeprazole after single dose | Day1 |
| Vd/F(Apparent volume of distribution) | Evaluation PK Rabeprazole after single dose | Day1 |
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Cmin,ss(Minimum concentration of drug in plasma at steady state) Cmin,SS(Minimum concentration of drug in plasma) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Cav,ss(Average concentration of drug in plasma at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Tmax,ss(Time to maximum plasma concentration at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| t1/2,ss(Terminal elimination half-life at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| CLss/F(Apparent Clearance at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Vss/F(Apparent Volume of distribution at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| PTF(Peak trough fluctuation over one dosing interal at steady state) | Evaluation PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| After the first administration of esomeprazole, The change of integrated gastric acidity compared to baseline for 24 hours | Evaluation PD Rabeprazole | Day1 24hours monitoring |
| After the first dose and 7 days of repeated dosing, Percentage of time to maintain gastric pH 4.0 or higher for 24 hours | Evaluation PD Rabeprazole | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring |
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | Evaluation PD Rabeprazole | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring |
| D004066 | Digestive System Diseases |