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

August 6, 2017 updated by: NVP Healthcare

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16209
        • Navipharm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVP-1402
NVP-1402 was administered once a day for 24 hours
Drug: NVP-1402
Oral
Active Comparator: NVP-1402R
Active comparator was administered twice a day for 24 hours
Drug: NVP-1402R
Oral
Other Names:
  • Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of plasma: Cmax
Time Frame: up to 24 hours after administration
Maximum measured concentration of the analyte in plasma
up to 24 hours after administration
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
up to 24 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 hours after administration
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
up to 24 hours after administration
Pharmacokinetics of plasma: t1/2
Time Frame: up to 24 hours after administration
Terminal half-life of the analyte in plasma
up to 24 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NVP Healthcare

Investigators

  • Principal Investigator: Young-Ran Yoon, M.D.,Ph.D., Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2017

Primary Completion (Actual)

July 3, 2017

Study Completion (Actual)

July 3, 2017

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 6, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • NVP-1402-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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