Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

Study Overview
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Brief Summary
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The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.

Detailed Description
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Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.

Official Title
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A Phase I Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and Safety After Administration of NVP-2002 and Co-administration of NVP-2002-R1 and NVP-2002-R2 in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: NVP-2002-R1+NVP-2002-R2
* Drug: NVP-2002


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adult subjects who signed informed consent Body Mass Index(BMI)=18.5 29.9kg/㎡ Exclusion Criteria: Subjects participated in another clinical trial within 6 months prior to administration of the study drug Inadequate subject for the clinical trial by the investigator's decision Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single tablet fist, fasted<br>single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition | Drug: NVP-2002-R1+NVP-2002-R2<br>* NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily<br>|
| Experimental: FDC fist, fasted<br>NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition | Drug: NVP-2002<br>* NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily<br>|
| Experimental: Single tablet fist, fed<br>single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition | Drug: NVP-2002-R1+NVP-2002-R2<br>* NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily<br>|
| Experimental: FDC fist, fed<br>NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition | Drug: NVP-2002<br>* NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of plasma: Cmax | Cmax of NVP-2002-R1 and NVP-2002-R2 | 0hours - 72hours | 
| Pharmacokinetics of plasma: AUCt | Area under the curve of NVP-2002-R1 and NVP-2002-R2 | 0hours - 72hours |