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The objective of this study is to compare pharmacokinetics after single oral administration of YH4808 and Diclofenac each separately versus coadministration of YH4808 and Diclofenac in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH4808 or Diclofenac or YH4808+Diclofenac(arm 1) | Experimental | 6 arm, 3 Sequence design
|
|
| YH4808 or Diclofenac or YH4808+Diclofenac (arm 2) | Experimental | 6 arm, 3 Sequence design
|
|
| YH4808 or Diclofenac or YH4808+Diclofenac (arm 3) | Experimental | 6 arm, 3 Sequence design
|
|
| YH4808 or Diclofenac or YH4808+Diclofenac (arm 4) | Experimental | 6 arm, 3 Sequence design
|
|
| YH4808 or Diclofenac or YH4808+Diclofenac (arm5) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH4808 | Drug | experimental drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of YH4808 | 18 points up to Day 2 or Day 3 | |
| AUClast of YH4808 | 18 points up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of YH4808 | 18 points up to Day 3 | |
| AUCinf of Diclofenac | 16points up to Day 2 | |
| t1/2 of YH4808 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janghee Hong, Professor | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea |
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| ID | Term |
|---|---|
| C000625316 | YH4808 |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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6 arm, 3 Sequence design
|
| YH4808 or Diclofenac or YH4808+Diclofenac (arm6) | Experimental | 6 arm, 3 Sequence design
|
|
| Diclofenac | Drug | Depain tablet 25mg |
|
|
| YH4808+Diclofenac | Drug |
|
| 18 points up to Day 3 |
| t1/2 of Diclofenac | 16 points up to Day 2 |
| Tmax of YH4808 | 18 points up to Day 3 |
| Tmax of Diclofenac | 16 points up to Day 2 |
| Metabolic ratio | 18 points up to Day 3 |