Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-03

Study Completion Date

2023-05-30

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single tablet fist, fasted

single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition

Group Type EXPERIMENTAL

NVP-2002-R1+NVP-2002-R2

Intervention Type DRUG

NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily

FDC fist, fasted

NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition

Group Type EXPERIMENTAL

NVP-2002

Intervention Type DRUG

NVP-2002 is a combination of NVP-2002-R1 and NVP-2002\_R2 NVP-2002, 1 tablet, once daily

Single tablet fist, fed

single tablets of NVP-2002-R1 and NVP-2002-R2 followed by NVP-2002 FDC, fasted condition

Group Type EXPERIMENTAL

NVP-2002-R1+NVP-2002-R2

Intervention Type DRUG

NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily

FDC fist, fed

NVP-2002 FDC followed by single tablets of NVP-2002-R1 and NVP-2002-R2, fasted condition

Group Type EXPERIMENTAL

NVP-2002

Intervention Type DRUG

NVP-2002 is a combination of NVP-2002-R1 and NVP-2002\_R2 NVP-2002, 1 tablet, once daily

Interventions

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NVP-2002-R1+NVP-2002-R2

NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily

Intervention Type DRUG

NVP-2002

NVP-2002 is a combination of NVP-2002-R1 and NVP-2002\_R2 NVP-2002, 1 tablet, once daily

Intervention Type DRUG

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes