Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

Phase 1CompletedNCT04961905

NVP Healthcare96 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

NVP-2002-R1+NVP-2002-R2DRUG

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

NVP-2002DRUG

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

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jeonbuk national university hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

Pharmacokinetics of plasma: Cmax

Cmax of NVP-2002-R1 and NVP-2002-R2

Time frame: 0hours - 72hours

Pharmacokinetics of plasma: AUCt

Area under the curve of NVP-2002-R1 and NVP-2002-R2

Time frame: 0hours - 72hours

Data from ClinicalTrials.gov

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