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Completed

NCT Number: NCT02897726

A Study to Evaluate the Safety and Pharmacokinetics of NVP-1402

The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

About this study

This study is designed as randomized, open-label, active-controlled and crossover assignment for evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects. The safety assessed through adverse events up to 17 days after administration. Additional variables (ECGs, laboratory test, vital signs, so on) will also be recorded and assessed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males
  • No history of clinically significant medical disorder
  • Capable of consent to participate in the study

Exclusion criteria

  • History of hypersensitive reactions to study drug or other related drugs
  • Any significant abnormality found during screening
  • Any significant medical history
  • History of alcohol abuse, smoking continuously
  • History of drug abuse
  • Clinically significant surgery within 4 weeks prior to administration of the study drug
  • Participation in another clinical trial within 3 months prior to administration of the study drug

Treatment and study plan

NVP-1402

Drug

Oral

NVP-1402R

Drug

Oral

Other names: Active comparator

Primary outcomes

  1. Pharmacokinetics of plasma: Cmax

    Time frame: up to 24 hours after administration

    Maximum measured concentration of the analyte in plasma

  2. Pharmacokinetics of plasma: AUClast

    Time frame: up to 24 hours after administration

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point

Secondary outcomes

  1. Pharmacokinetics of plasma: AUCinf

    Time frame: up to 24 hours after administration

    Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

  2. Pharmacokinetics of plasma: Tmax

    Time frame: up to 24 hours after administration

    Time from dosing to the maximum measured concentration of the analyte in plasma

  3. Pharmacokinetics of plasma: t1/2

    Time frame: up to 24 hours after administration

    Terminal half-life of the analyte in plasma

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

A Clinical Trial to Evaluate the Pharmacokinetics and Safety of NVP-1402 in Healthy Male Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2016
Registry last updated
Aug 8, 2017

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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