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Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2

NCT ID: NCT04181437

Last Updated: 2020-09-01

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-05-29

Brief Summary

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The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

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Detailed Description

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pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

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-R1

Drug: NVP-1203-R1

1 tablet, oral dosing

Group Type EXPERIMENTAL

NVP-1203-R1

Intervention Type DRUG

1 tablet, Single oral dosing

NVP-1203-R2

Drug: NVP-1203-R2

1 tablet, oral dosing

Group Type EXPERIMENTAL

NVP-1203-R2

Intervention Type DRUG

1 tablet, Single oral dosing

NVP-1203-R1 and NVP-1203-R2

Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)

Group Type EXPERIMENTAL

NVP-1203-R1 and NVP-1203-R2

Intervention Type DRUG

NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing

Interventions

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NVP-1203-R1

1 tablet, Single oral dosing

Intervention Type DRUG

NVP-1203-R2

1 tablet, Single oral dosing

Intervention Type DRUG

NVP-1203-R1 and NVP-1203-R2

NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing

Intervention Type DRUG

Other Intervention Names

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NVP-1203-R1(A) NVP-1203-R2(E) NVP-1203-R1(A) and NVP-1203-R2(E)

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 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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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_DDI

Identifier Type: -

Identifier Source: org_study_id

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