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
| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects
This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YPI-011 10/500mg | Experimental | Part A: 1 tablet administered before the breakfast during 7 days |
|
| YPI-011 20/500mg | Experimental | Part B: 1 tablet administered before the breakfast during 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole Sodium 10mg | Drug | Part A: 1 tablet administered before the breakfast during 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Integrated gastric acidity | Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 7th dose | From Day 1 up to Day 28 |
| AUCt,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent decrease from baseline in integrated gastric acidity for 24 hour interval after 1 st dose | Evaluateion PD Rabeprazole after multiple dose | 24 hours |
| Percent of time with gastric pH>4 for 24 hour interval after 1st and 7th 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 | Daehak-ro Jongno-gu | 110-744 | South Korea |
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 |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rabeprazole Sodium 20mg | Drug | Part B: 1 tablet administered before the breakfast during 7 days |
|
|
Evaluateion PD Rabeprazole after multiple dose
| From Day 1 up to Day 28 |
| Mean and median gastric pH after 1st and 7th dose | Evaluateion PD Rabeprazole after multiple dose | From Day 1 up to Day 28 |
| AUCĪ | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Cmax | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Tmax | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| t1/2 | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| CL/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Vz/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Cmin,ss, | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Cmax,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Cav,ss, | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Tmax,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| t1/2,ss | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| CLss/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| Vss/F | Evaluateion PK Rabeprazole after multiple dose | From Day 1 up to Day 29 |
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |