Evaluation of Pharmacokinetic and Safety of NVP-2102 and NVP-2102-R in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.

Detailed Description
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Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R

Official Title
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A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: NVP-2102
* Drug: NVP-2102-R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subject, 19 years of age or older Subjects who signed informed consent Body mass index(BMI) of 18 to 30.0 kg/㎡ Exclusion Criteria: Subject who has clinically significant medical history Inadequate subject for the clinical trial by the investigator's decision Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

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: NVP-2102<br>NVP-2102 | Drug: NVP-2102<br>* Tablet formulation for oral administration, single dose of NVP-2102 at Day 1<br>|
| Active Comparator: NVP-2102-R<br>NVP-2102-R | Drug: NVP-2102-R<br>* Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Area under the plasma drug concentration-time curve(AUCt) | Pharmacokinetics parameter derived from plasma | 0   72 hours | 
| Evaluation of Maximum observed plasma concentration(Cmax) | Pharmacokinetics parameter derived from plasma | 0   72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) | Pharmacokinetics parameter derived from plasma | 0   72 hours | 
| Evaluation of AUCt/AUC∞ | Pharmacokinetics parameter derived from plasma | 0   72 hours | 
| Evaluation of Time of peak concentration(Tmax) | Pharmacokinetics parameter derived from plasma | 0   72 hours | 
| Evaluation of Terminal phase of Half-life(t1/2) | Pharmacokinetics parameter derived from plasma | 0   72 hours | 
| Evaluation of total clearance of the drug from plasma after oral administration(CL/F) | Pharmacokinetics parameter derived from plasma | 0   72 hours | 
| Evaluation of volume of distribution after non-intravenous administration(Vz/F) | Pharmacokinetics parameter derived from plasma | 0   72 hours |