NCT02897726

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

March 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

September 1, 2016

Last Update Submit

August 6, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of plasma: Cmax

    Maximum measured concentration of the analyte in plasma

    up to 24 hours after administration

  • Pharmacokinetics of plasma: AUClast

    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 Outcomes (3)

  • Pharmacokinetics of plasma: AUCinf

    up to 24 hours after administration

  • Pharmacokinetics of plasma: Tmax

    up to 24 hours after administration

  • Pharmacokinetics of plasma: t1/2

    up to 24 hours after administration

Study Arms (2)

NVP-1402

EXPERIMENTAL

NVP-1402 was administered once a day for 24 hours

Drug: NVP-1402

NVP-1402R

ACTIVE COMPARATOR

Active comparator was administered twice a day for 24 hours

Drug: NVP-1402R

Interventions

NVP-1402DRUG

Oral

NVP-1402
NVP-1402RDRUG

Oral

Also known as: Active comparator
NVP-1402R

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

Location

Study Officials

  • Young-Ran Yoon, M.D.,Ph.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 13, 2016

Study Start

March 24, 2017

Primary Completion

July 3, 2017

Study Completion

July 3, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)