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The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203
This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP-1203(fed then fasting) | Experimental | Subjects will receive a oral dose of NVP-1203 under fed conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fasting conditions in period 2 |
|
| NVP-1203(fasting then fed) | Experimental | Subjects will receive a oral dose of NVP-1203 under fasting conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fed conditions in period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-1203 | Drug | Oral |
| |
| NVP-1203 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics : Cmax | Maximum plasma concentration | 0-24 hours |
| Pharmacokinetics : AUCt | Area under the concentration-time curve | 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics : AUCinf | AUC extrapolated to infinity | 0-24 hours |
| Pharmacokinetics : Tmax | Time to reach the Cmax | 0-24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon Y Ran, M.D. | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | Dongdeok-ro | 700-721 | South Korea |
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| Drug |
Oral |
|
| Pharmacokinetics : t1/2 | Terminal elimination half-life | 0-24 hours |