Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2

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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2019-09-27

Brief Summary

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The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

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Detailed Description

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pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-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-1805-R1

Drug: NVP-1805-R1

1 tablet, oral dosing

Group Type EXPERIMENTAL

NVP-1805-R1

Intervention Type DRUG

1 tablet, multiple oral dosing

NVP-1805-R2

Drug: NVP-1805-R2

1 tablet, oral dosing

Group Type EXPERIMENTAL

NVP-1805-R2

Intervention Type DRUG

1 tablet, multiple oral dosing

NVP-1805-R1 and NVP-1805-R2

Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)

Group Type EXPERIMENTAL

NVP-1805-R1 and NVP-1805-R2

Intervention Type DRUG

NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing

Interventions

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NVP-1805-R1

1 tablet, multiple oral dosing

Intervention Type DRUG

NVP-1805-R2

1 tablet, multiple oral dosing

Intervention Type DRUG

NVP-1805-R1 and NVP-1805-R2

NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing

Intervention Type DRUG

Other Intervention Names

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NVP-1805-R1(M) NVP-1805-R2(C) NVP-1805-R1(M) and NVP-1805-R2(C)

Eligibility Criteria

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Inclusion Criteria

* Male or female adults aged 19-45 years.
* BMI of \>18.5 kg/㎡ and \<27.0 kg/㎡ subject, weight more than 50kg.
* Voluntarily provided a witten consent to participate in this clinical study.

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
* Pregnant or lactating women.

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes