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

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: NVP-1402; Drug: NVP-1402R

Study type: Interventional

Funder types: Industry

Identifiers

NCT02897726

NVP-1402-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 38 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

NVP-1402

Experimental group

Description:

NVP-1402 was administered once a day for 24 hours

Treatment:

Drug: NVP-1402

NVP-1402R

Active Comparator group

Description:

Active comparator was administered twice a day for 24 hours

Treatment:

Drug: NVP-1402R