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Completed

NCT Number: NCT04181437

Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Completed

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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

Kyungpook National University Hospital

Daegu, Dongdeok-ro, 700-721, South Korea

About this study

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

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

Exclusion criteria

  • Subjects has a history of allergy reaction of study drug ingredient
  • 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-1203-R1

Drug

1 tablet, Single oral dosing

Other names: NVP-1203-R1(A)

NVP-1203-R2

Drug

1 tablet, Single oral dosing

Other names: NVP-1203-R2(E)

NVP-1203-R1 and NVP-1203-R2

Drug

NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing

Other names: NVP-1203-R1(A) and NVP-1203-R2(E)

Primary outcomes

  1. Pharmacokinetic interaction

    Time frame: 0hours - 24hours

    Area under the curve (AUC)

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects

Acronym: Navipharm

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
Sep 1, 2020

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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