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The objective of this clinical trial is to explore pharmacodynamics and pharmacokinetics of YH4808 New Formulation in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1-YH4808 NF 100 | Experimental | 7 days repeat administration of YH4808 New Formulation 100mg after meal |
|
| Cohort1-YH4808 OF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 Old Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 New Formulation 200mg after meal |
|
| Cohort1-YH4808 NF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg after meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg after meal |
|
| Cohort1-YH4808 NF 400 | Experimental | 7 days repeat administration of YH4808 New Formulation 400mg after meal |
|
| Cohort2-YH4808 NF 100 | Experimental | 7 days repeat administration of YH4808 New Formulation 100mg before meal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH4808 NF 100 | Drug | The number of times : multiple-dose Rout : oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Cmax of YH4808 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) |
| The AUC0-24h of YH4808 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) |
| The AUC0-24h of M3 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) |
| The Cmax of M3 | Day 1(Day 35); predose, 11 times after dosing, Day 7(Day 41); predose, 13 times after dosing | Day 1(Day 35), Day 7(Day 41) |
| Measure | Description | Time Frame |
|---|---|---|
| the arithmetic mean of 24h intragastric pH monitoring | Day 1(Day7)~Day2(Day8) | |
| the median of 24h intragastric pH monitoring | Day 1(Day7)~Day2(Day8) | |
| The Duration of stomach maintained over pH4 or 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min soo Park, Ph.D, M.D. | Yonsei Medical Center Severance Hospital Clinical Trials Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Medical Center Severance Hospital Clinical Trials Center | Seoul | South Korea |
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| Cohort2-YH4808 NF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal |
|
| Cohort2-YH4808 OF 200 | Experimental | (Partial cross over design) 7 days repeat administration of YH4808 New Formulation 200mg before meal, 4 Weeks of wash out period, 7 days repeat administration of YH4808 Old Formulation 200mg before meal |
|
| Cohort2-YH4808 NF 400 | Experimental | 7 days repeat administration of YH4808 New Formulation 400mg before meal |
|
| Cohort3-YH4808 OF 200 | Experimental | (Partial cross over design)
|
|
| Cohort3-YH4808 OF 400 | Experimental | (Partial cross over design)
|
|
| YH4808 OF 200 | Drug | The number of times : multiple-dose Rout : oral administration |
|
| YH4808 NF 200 | Drug | The number of times : multiple-dose Rout : oral administration |
|
| YH4808 NF 400 | Drug | The number of times : multiple-dose Rout : oral administration |
|
| Day 1(Day7)~Day2(Day8) |