NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

NCT ID: NCT04905342

Last Updated: 2022-02-11

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

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-14

Study Completion Date

2022-01-07

Brief Summary

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The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

Detailed Description

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Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

single-dose, crossover study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVP-1805

NVP-1805 (80/10/20.8mg)

Group Type EXPERIMENTAL

NVP-1805

Intervention Type DRUG

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)

NVP-1805-R1 and NVP-1805-R2

coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)

Group Type ACTIVE_COMPARATOR

NVP-1805-R1and NVP-1805-R2

Intervention Type DRUG

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)

Interventions

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NVP-1805

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)

Intervention Type DRUG

NVP-1805-R1and NVP-1805-R2

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/㎡ and \<30.0 kg/㎡ 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
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
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, M.D.

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-1805_BE-02

Identifier Type: -

Identifier Source: org_study_id

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