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Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of DW1903

NCT ID: NCT05155072

Last Updated: 2021-12-13

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-09-07

Brief Summary

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A Randomized, Open-label, Oral in healthy male volunteers

Detailed Description

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Conditions

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Gastritis

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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Sequence A

Group Type EXPERIMENTAL

DW1903

Intervention Type DRUG

DW1903

DW1903-R1

Intervention Type DRUG

DW1903-R1

DW1903-R2

Intervention Type DRUG

DW1903-R2

Sequence B

Group Type EXPERIMENTAL

DW1903

Intervention Type DRUG

DW1903

DW1903-R1

Intervention Type DRUG

DW1903-R1

DW1903-R2

Intervention Type DRUG

DW1903-R2

Sequence C

Group Type EXPERIMENTAL

DW1903

Intervention Type DRUG

DW1903

DW1903-R1

Intervention Type DRUG

DW1903-R1

DW1903-R2

Intervention Type DRUG

DW1903-R2

Sequence D

Group Type EXPERIMENTAL

DW1903

Intervention Type DRUG

DW1903

DW1903-R1

Intervention Type DRUG

DW1903-R1

DW1903-R2

Intervention Type DRUG

DW1903-R2

Sequence E

Group Type EXPERIMENTAL

DW1903

Intervention Type DRUG

DW1903

DW1903-R1

Intervention Type DRUG

DW1903-R1

DW1903-R2

Intervention Type DRUG

DW1903-R2

Sequence F

Group Type EXPERIMENTAL

DW1903

Intervention Type DRUG

DW1903

DW1903-R1

Intervention Type DRUG

DW1903-R1

DW1903-R2

Intervention Type DRUG

DW1903-R2

Interventions

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DW1903

DW1903

Intervention Type DRUG

DW1903-R1

DW1903-R1

Intervention Type DRUG

DW1903-R2

DW1903-R2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteers who are ≥19 years old
* BMI between 18 and 30 kg/m2
* Body weight ≥50kg

Exclusion Criteria

•Clinically significant Medical History
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW1903-101D

Identifier Type: -

Identifier Source: org_study_id