A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203

NCT ID: NCT02289404

Last Updated: 2019-03-08

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2019-02-28

Brief Summary

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The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203

Detailed Description

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This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVP-1203(fed then fasting)

Subjects will receive a oral dose of NVP-1203 under fed conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fasting conditions in period 2

Group Type EXPERIMENTAL

NVP-1203

Intervention Type DRUG

Oral

NVP-1203(fasting then fed)

Subjects will receive a oral dose of NVP-1203 under fasting conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fed conditions in period 2

Group Type EXPERIMENTAL

NVP-1203

Intervention Type DRUG

Oral

Interventions

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NVP-1203

Oral

Intervention Type DRUG

NVP-1203

Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy adult subjects who signed informed consent

Exclusion Criteria

* Subjects has a history of allergy reaction of study drug ingredient
* Subjects participated in another clinical trial within 3 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NVP Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoon Y Ran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National University Hospital

Daegu, Dongdeok-ro, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NVP-1203_FE

Identifier Type: -

Identifier Source: org_study_id

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