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A study to compare safety, pharmacokinetics and pharmacodynamics of AD-206 to Esomeprazole in healthy male volunteers.
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of AD-206 compared with administration of Esomeprazole in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 | Experimental | Period 1: Test Drug(AD-206 20mg) Period 2: Reference Drug(Esomeprazole 20mg) |
|
| Group A2 | Experimental | Period 1: Reference Drug(Esomeprazole 20mg) Period 2: Test Drug(AD-206 20mg) |
|
| Group B1 | Experimental | Period 1: Test Drug(AD-206 40mg) Period 2: Reference Drug(Esomeprazole 40mg) |
|
| Group B2 | Experimental | Period 1: Reference Drug(Esomeprazole 40mg) Period 2: Test Drug(AD-206 40mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-206 20mg | Drug | 1 tablet administered before the breakfast during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss(Area under the plasma drug concentration-time curve) | Evaluation PK esomeprazole 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 esomeprazole after multiple dose | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau(Area under the plasma drug concentration-time curve) | Evaluation PK esomeprazole after single dose | Day1 |
| Cmax(Maximum concentration of drug in plasma) | Evaluation PK esomeprazole after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, 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 |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D009853 | Omeprazole |
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| Esomeprazole 20mg | Drug | 1 tablet administered before the breakfast during 7 days |
|
|
| AD-206 40mg | Drug | 1 tablet administered before the breakfast during 7 days |
|
|
| Esomeprazole 40mg | Drug | 1 tablet administered before the breakfast during 7 days |
|
|
| Day1 |
| Tmax(Time to maximum plasma concentration) | Evaluation PK esomeprazole after single dose | Day1 |
| t1/2(Terminal elimination half-life) | Evaluation PK esomeprazole after single dose | Day1 |
| CL/F(Apparent clearance) | Evaluation PK esomeprazole after single dose | Day1 |
| Vd/F(Apparent volume of distribution) | Evaluation PK esomeprazole after single dose | Day1 |
| Cmax,ss(Maximum concentration of drug in plasma at steady state) | Evaluation PK esomeprazole 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 esomeprazole after multiple dose | From Day 1 up to Day 29 |
| Cav,ss(Average concentration of drug in plasma at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 |
| Tmax,ss(Time to maximum plasma concentration at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 |
| t1/2,ss(Terminal elimination half-life at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 |
| CLss/F(Apparent Clearance at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 |
| Vss/F(Apparent Volume of distribution at steady state) | Evaluation PK esomeprazole after multiple dose | From Day 1 up to Day 29 |
| PTF(Peak trough fluctuation over one dosing interal at steady state) | Evaluation PK esomeprazole 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 esomeprazole | Day1 24hrs pH 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 esomeprazole | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring |
| After the first administration and 7 days of repeated administration, The median pH measured for 24 hours | Evaluation PD esomeprazole | Day1 24hrs pH monitoring, Day7 24hrs pH monitoring |
| D053799 |
| 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |