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

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2017-07-03

Brief Summary

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The purpose of this study is to evaluate and compare the safety and pharmacokinetics of NVP-1402 and NVP-1402R in healthy male subjects.

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Detailed Description

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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.

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

NVP-1402 was administered once a day for 24 hours

Group Type EXPERIMENTAL

NVP-1402

Intervention Type DRUG

Oral

NVP-1402R

Active comparator was administered twice a day for 24 hours

Group Type ACTIVE_COMPARATOR

NVP-1402R

Intervention Type DRUG

Oral

Interventions

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NVP-1402

Oral

Intervention Type DRUG

NVP-1402R

Oral

Intervention Type DRUG

Other Intervention Names

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Active comparator

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