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

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: Healthy
• Intervention / Treatment: Drug: NVP-1402; Drug: NVP-1402R

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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 Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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