The Food Effect on the Pharmacokinetics of NVP-1402

NCT ID: NCT03340480

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2018-05-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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NVP-1402-1

NVP-1402 was administered once a day for 24 hours

Group Type EXPERIMENTAL

NVP-1402

Intervention Type DRUG

Oral

NVP-1402-2

NVP-1402 was administered once a day for 24 hours

Group Type EXPERIMENTAL

NVP-1402

Intervention Type DRUG

Oral

Interventions

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NVP-1402

Oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NVP Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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D Seong Shin

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

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Navipharm

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NVP-1402-02

Identifier Type: -

Identifier Source: org_study_id

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