The Food Effect on the Pharmacokinetics of NVP-1402

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03340480

Enrollment

Registered

2017-11-13

Start date

2017-12-12

Completion date

2018-05-02

Last updated

2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed 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.

Interventions

DRUGNVP-1402

Oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics of plasma: Cmax	up to 24 hours after administration	Maximum measured concentration of the analyte in plasma
Pharmacokinetics of plasma: AUClast	up to 24 hours after administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point

Secondary

Measure	Time frame	Description
Pharmacokinetics of plasma: AUCinf	up to 24 hours after administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
Pharmacokinetics of plasma: Tmax	up to 24 hours after administration	Time from dosing to the maximum measured concentration of the analyte in plasma
Pharmacokinetics of plasma: t1/2	up to 24 hours after administration	Terminal half-life of the analyte in plasma

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026