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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NVP-1402; Drug: NVP-1402R

• Registration Number: NCT02897726
• Lead Sponsor: NVP Healthcare

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.

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 Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2017-03-24
• Primary Completion: 2017-07-03
• Study Completion: 2017-07-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-06
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NVP-1402	NVP-1402	NVP-1402 was administered once a day for 24 hours
NVP-1402R	NVP-1402R	Active comparator was administered twice a day for 24 hours

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of plasma: Cmax	up to 24 hours after administration	Maximum measured concentration of the analyte in plasma
Pharmacokinetics of plasma: AUClast	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 Outcome Measures

Name	Time	Method
Pharmacokinetics of plasma: AUCinf	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
Pharmacokinetics of plasma: Tmax	up to 24 hours after administration	Time from dosing to the maximum measured concentration of the analyte in plasma
Pharmacokinetics of plasma: t1/2	up to 24 hours after administration	Terminal half-life of the analyte in plasma

Trial Locations

Locations (1)

Navipharm; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of