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

NVP Healthcare38 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

NVP-1402DRUG

Oral

NVP-1402RDRUG

Oral

Eligibility

Sex: MALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Navipharm

Suwon, Gyeonggi-do, South Korea