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Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects

NCT ID: NCT05149274

Last Updated: 2021-12-08

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2021-10-26

Brief Summary

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The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.

Detailed Description

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Conditions

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Phase 1 Study, Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part1

DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study

Group Type ACTIVE_COMPARATOR

DWP14012 Tablet A

Intervention Type DRUG

DWP14012 10mg

Part2

DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T

Group Type ACTIVE_COMPARATOR

DWP14012 Tablet A

Intervention Type DRUG

DWP14012 10mg

DWP14012 Tablet B

Intervention Type DRUG

DWP14012 40mg

Interventions

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DWP14012 Tablet A

DWP14012 10mg

Intervention Type DRUG

DWP14012 Tablet B

DWP14012 40mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults \>=19years and \<=45 years of age
* BMI \>=17.5 kg/m2 and \<30.5kg/m2, and body weight \>= 55kg for male and \>= 45kg for femlae
* subjects with no abnormal symptoms or findings based on physical examinations
* subjects determined eligible based on the results of lab tests
* subjects who agree to participate

Exclusion Criteria

* Subjects with medical history that can not be participated
* Subjects with results of lab tests performed at screening which meet any of the following :

* ALT or AST \> 1.5 times the upper limit of normal
* Diagnosis of Helicobacter pylori (H. pylori) positive result
* subject who is allergic to IP
* subject with history of serious alcohol or drug abuse within 1 year prior to screening.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 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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Bundang CHA Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWP14012107

Identifier Type: -

Identifier Source: org_study_id