The Food Effect on the Pharmacokinetics of NVP-1402

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NVP-1402

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 Type: Interventional
• Enrollment (Actual): 32
• 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: Yes
• 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-1402-1; NVP-1402 was administered once a day for 24 hours	Drug: NVP-1402; Oral
Experimental: NVP-1402-2; NVP-1402 was administered once a day for 24 hours	Drug: NVP-1402; Oral

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: D Seong Shin, Gachon University Gil Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2017
• Primary Completion (Actual): January 8, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NVP-1402-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No