The Food Effect on the Pharmacokinetics of NVP-1402

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: NVP-1402

Study type: Interventional

Funder types: Industry

Identifiers

NCT03340480

NVP-1402-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 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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32 participants in 2 patient groups

NVP-1402-1

Experimental group

Description:

NVP-1402 was administered once a day for 24 hours

Treatment:

Drug: NVP-1402

NVP-1402-2

Experimental group

Description:

NVP-1402 was administered once a day for 24 hours

Treatment:

Drug: NVP-1402