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
Not provided
Not provided
The main objective is to evaluate the food effect on the pharmacokinetic profile of YH4808 100 mg b.i.d and YH4808 300 mg after oral administration in healthy male subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
| |
| Sequence 3 | Experimental |
| |
| Sequence 4 | Experimental |
| |
| Sequence 5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH4808 100 mg | Drug | Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve of YH4808 | non-compartmental analysis | Blood sampling during 24 or 48 hrs after administration |
| Peak plasma concentration of YH4808 | non-compartmental analysis | Blood sampling during 24 or 48 hrs after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach peak plasma concentration of YH4808 | non-compartmental analysis | Blood sampling during 24 or 48 hrs after administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuhan Corporation | Seoul | 156-754 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29907887 | Derived | Kim E, Kim A, Yi S, Kim YK, Jang SB, Byun HM, Yoon SH, Cho JY, Jang IJ, Yu KS, Lee S. Effect of food on the pharmacokinetics of YH4808, a potassium-competitive acid blocker, after single- and multiple-oral dosing in healthy subjects. Eur J Clin Pharmacol. 2018 Oct;74(10):1261-1272. doi: 10.1007/s00228-018-2502-9. Epub 2018 Jun 15. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000625316 | YH4808 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| YH4808 100 mg | Drug | Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days |
|
| YH4808 300 mg | Drug | Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal) |
|
| YH4808 300 mg | Drug | Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal) |
|
| YH4808 300 mg | Drug | Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition |
|