Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2

NCT ID: NCT03220399

Last Updated: 2019-08-26

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-07-31

Brief Summary

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The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Detailed Description

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pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

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-1603-1 (P)

Drug: NVP-1603-1

1capsule, oral dosing

Group Type EXPERIMENTAL

NVP-1603-1 (P)

Intervention Type DRUG

1capsule, single oral dosing

NVP-1603-2(T)

Drug: NVP-1603-2

1Tablet, oral dosing

Group Type EXPERIMENTAL

NVP-1603-2 (T)

Intervention Type DRUG

1tablet, single oral dosing

NVP-1603-1and NVP-1603-2 (P+T)

Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing)

Group Type EXPERIMENTAL

NVP-1603-1 and NVP-1603-2 (P+T)

Intervention Type DRUG

1capsule and 1tablet co-administration, oral single dosing

Interventions

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NVP-1603-1 (P)

1capsule, single oral dosing

Intervention Type DRUG

NVP-1603-2 (T)

1tablet, single oral dosing

Intervention Type DRUG

NVP-1603-1 and NVP-1603-2 (P+T)

1capsule and 1tablet co-administration, oral single dosing

Intervention Type DRUG

Other Intervention Names

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NVP-1603-1 NVP-1603-2 NVP-1603-1 and NVP-1603-2

Eligibility Criteria

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Inclusion Criteria

* Men 19years of age or older at screening test.
* BMI of \>18.5kg/㎡ and \<27.0kg/㎡ subject, weight more than 50kg.
* Subject has signed and dated informed consent.

Exclusion Criteria

* Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
* History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
* Current alcohol abuse.
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NVP Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NVP-1603_P1_DDI

Identifier Type: -

Identifier Source: org_study_id

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