Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.
This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD-214/Rabeprazole | Experimental | Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg) |
|
| Rabeprazole/AD-214 | Experimental | Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-214 10/600mg | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rabeprazole 10mg | 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 Rabeoprazoke | 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 Rabeoprazoke | 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 Rabeoprazoke | Day1 24hours pH monitoring, Day7 24hours pH monitoring, Day22 24hours monitoring, Day28 24hours pH monitoring |
| D004066 | Digestive System Diseases |
| 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 |