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The purpose of this study is to evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male volunteers.
This study is designed as randomized, open-label, single oral dose, two-treatment, two sequence crossover active-controlled and crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP-1402-1 | Experimental | NVP-1402 was administered once a day for 24 hours |
|
| NVP-1402-2 | Experimental | NVP-1402 was administered once a day for 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-1402 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of plasma: Cmax | Maximum measured concentration of the analyte in plasma | up to 24 hours after administration |
| Pharmacokinetics of plasma: AUClast | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point | up to 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of plasma: AUCinf | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity | up to 24 hours after administration |
| Pharmacokinetics of plasma: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D Seong Shin | Gachon University Gil Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navipharm | Suwon | Gyeonggi-do | 16209 | South Korea |
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Time from dosing to the maximum measured concentration of the analyte in plasma
| up to 24 hours after administration |
| Pharmacokinetics of plasma: t1/2 | Terminal half-life of the analyte in plasma | up to 24 hours after administration |