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

December 10, 2021 updated by: Daewon Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Cheongju-si, Korea, Republic of
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
Drug: DW1903
DW1903
Drug: DW1903-R1
DW1903-R1
Drug: DW1903-R2
DW1903-R2
Experimental: Sequence B
Drug: DW1903
DW1903
Drug: DW1903-R1
DW1903-R1
Drug: DW1903-R2
DW1903-R2
Experimental: Sequence C
Drug: DW1903
DW1903
Drug: DW1903-R1
DW1903-R1
Drug: DW1903-R2
DW1903-R2
Experimental: Sequence D
Drug: DW1903
DW1903
Drug: DW1903-R1
DW1903-R1
Drug: DW1903-R2
DW1903-R2
Experimental: Sequence E
Drug: DW1903
DW1903
Drug: DW1903-R1
DW1903-R1
Drug: DW1903-R2
DW1903-R2
Experimental: Sequence F
Drug: DW1903
DW1903
Drug: DW1903-R1
DW1903-R1
Drug: DW1903-R2
DW1903-R2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH monitoring
Time Frame: up to day 5
Pharmacodynamic Endpoint
up to day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

September 7, 2020

Study Completion (Actual)

September 7, 2020

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW1903-101D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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