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The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.
This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVP-1402 | Experimental | NVP-1402 was administered once a day for 24 hours |
|
| NVP-1402R | Active Comparator | Active comparator was administered twice a day for 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVP-1402 | Drug | Oral |
| |
| NVP-1402R |
| 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 |
|---|---|---|
| Young-Ran Yoon, M.D.,Ph.D. | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navipharm | Suwon | Gyeonggi-do | 16209 | South Korea |
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| Drug |
Oral |
|
|
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 |