Pharmacokinetics and Safety of DWJ1451 in Healthy Adults

NCT ID: NCT04819932

Last Updated: 2021-03-29

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-13

Study Completion Date

2021-04-02

Brief Summary

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Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax

Detailed Description

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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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group1

subject take DWC202008 and DWC2020091 on a fasted condition, and after wash out period, take DWJ1451 with on a fasted condition

Group Type EXPERIMENTAL

DWJ1451

Intervention Type DRUG

DWC202008 DWC202009

group2

subject take DWJ1451 on a fasted condition, and after wash out period, take DWC202008 and DWC202009 with on a fasted condition

Group Type EXPERIMENTAL

DWJ1451

Intervention Type DRUG

DWC202008 DWC202009

Interventions

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DWJ1451

DWC202008 DWC202009

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 19 to 55 years
* Healthy Adult

Exclusion Criteria

* Non-Healthy
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ1451102

Identifier Type: -

Identifier Source: org_study_id

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