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Completed

NCT Number: NCT03340480

The Food Effect on the Pharmacokinetics of NVP-1402

The purpose of this study is to evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male volunteers.

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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, single oral dose, two-treatment, two sequence crossover active-controlled and crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1402 in healthy male subjects.

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

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2017
Registry last updated
May 17, 2018

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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