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NCT Number: NCT04961905

Pharmacokinetic Characteristics and Safety After Administration of NVP-2002

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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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk national university hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NVP-2002-R1+NVP-2002-R2

Drug

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

NVP-2002

Drug

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

Primary outcomes

  1. Pharmacokinetics of plasma: Cmax

    Time frame: 0hours - 72hours

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

  2. Pharmacokinetics of plasma: AUCt

    Time frame: 0hours - 72hours

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

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2021
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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