To Evaluate the Safety and the Pharmacokinetics of NVP-2203

NCT ID: NCT05725252

Last Updated: 2024-01-11

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-28

Study Completion Date

2023-07-05

Brief Summary

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The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Detailed Description

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Phase 1 to evaluate the safety and pharmacokinetics after administration of NVP-2203.

Conditions

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Healthy Volunteers

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-2203

After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)

Group Type EXPERIMENTAL

NVP-2203

Intervention Type DRUG

NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)

NVP-2203-R

After fasting (except water) for at least 10 hours before dosing, oral administration of investigational product once daily on Period 1(or Period 2)

Group Type ACTIVE_COMPARATOR

NVP-2203-R

Intervention Type DRUG

administration of active comparator

Interventions

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NVP-2203

NVP-2203(Combination of NVP-2203-R1 and NVP-2203-R2)

Intervention Type DRUG

NVP-2203-R

administration of active comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/m2 and \<30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria

* Subjects participated in another clinical trial within 6 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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Jaewoo Kim

Role: PRINCIPAL_INVESTIGATOR

H Plus Yangji Hospital

Locations

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H Plus Yangji Hospital

Seoul, Nambusunhwan-ro, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NVP-2203_BA

Identifier Type: -

Identifier Source: org_study_id

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