The Food Effect on the Pharmacokinetics of NVP-1402

Phase 1

Completed

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

• Registration Number: NCT03340480
• Lead Sponsor: NVP Healthcare

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-13
• Study Start: 2017-12-12
• Primary Completion: 2018-01-08
• Status Verified: 2018-03
• Study Completion: 2018-05-02
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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-1402-2	NVP-1402	NVP-1402 was administered once a day for 24 hours
NVP-1402-1	NVP-1402	NVP-1402 was administered once 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