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NCT05155072 Clinical Trial

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

Gastritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05155072
Other study ID # DW1903-101D
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 15, 2020
Est. completion date September 7, 2020

Study information
Verified date October 2021
Source Daewon Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date September 7, 2020
Est. primary completion date September 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• DW1903
DW1903
• DW1903-R1
DW1903-R1
• DW1903-R2
DW1903-R2

Locations
Country Name City State
Korea, Republic of Chungbuk National University Hospital Cheongju-si

Sponsors (1)
Lead Sponsor Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary pH monitoring Pharmacodynamic Endpoint up to day 5
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