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

Primary Purpose

Gastritis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

DW1903

DW1903-R1

DW1903-R2

About this trial

This is an interventional treatment trial for Gastritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Chungbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Sequence A

Sequence B

Sequence C

Sequence D

Sequence E

Sequence F

Arm Description

Outcomes

Primary Outcome Measures

pH monitoring

Pharmacodynamic Endpoint

Secondary Outcome Measures

Full Information

NCT ID

NCT05155072

First Posted

October 28, 2021

Last Updated

December 10, 2021

Sponsor

Daewon Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05155072

Brief Title

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

Official Title

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of DW1903, DW1903-R1 and DW1903-R2 in Healthy Adult Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

May 15, 2020 (Actual)

Primary Completion Date

September 7, 2020 (Actual)

Study Completion Date

September 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daewon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence A

Arm Type

Experimental

Arm Title

Sequence B

Arm Type

Experimental

Arm Title

Sequence C

Arm Type

Experimental

Arm Title

Sequence D

Arm Type

Experimental

Arm Title

Sequence E

Arm Type

Experimental

Arm Title

Sequence F

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

DW1903

Intervention Description

DW1903

Intervention Type

Drug

Intervention Name(s)

DW1903-R1

Intervention Description

DW1903-R1

Intervention Type

Drug

Intervention Name(s)

DW1903-R2

Intervention Description

DW1903-R2

Primary Outcome Measure Information:

Title

pH monitoring

Description

Pharmacodynamic Endpoint

Time Frame

up to day 5

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Chungbuk National University Hospital

City

Cheongju-si

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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