A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Trial to Evaluate the Pharmacokinetics and Safety of NVP-1402 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: NVP-1402
* Drug: NVP-1402R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males No history of clinically significant medical disorder Capable of consent to participate in the study Exclusion Criteria: History of hypersensitive reactions to study drug or other related drugs Any significant abnormality found during screening Any significant medical history History of alcohol abuse, smoking continuously History of drug abuse Clinically significant surgery within 4 weeks prior to administration of the study drug Participation in another clinical trial within 3 months prior to administration of the study drug

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1402<br>NVP-1402 was administered once a day for 24 hours | Drug: NVP-1402<br>* Oral<br>|
| Active Comparator: NVP-1402R<br>Active comparator was administered twice a day for 24 hours | Drug: NVP-1402R<br>* Oral<br>* Other names: Active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |