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OpenTrials
Completed

NCT Number: NCT05725252

To Evaluate the Safety and the Pharmacokinetics of NVP-2203

The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

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Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, Nambusunhwan-ro, 08779, South Korea

About this study

Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

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
  • BMI of >18.0 kg/m2 and <30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

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

Treatment and study plan

NVP-2203

Drug

NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)

NVP-2203-R

Drug

administration of active comparator

Primary outcomes

  1. NVP-2203's pharmacokinetics of plasma

    Time frame: 0hours - 72hours

    AUCt

Secondary outcomes

  1. pharmacokinetics of plasma

    Time frame: 0hours - 72hours

    Cmax

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of NVP-2203 in Healthy Adult Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Jan 11, 2024

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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