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

Phase 1

Completed

• Conditions: Gastritis
• Interventions: Drug: DW1903; Drug: DW1903-R1; Drug: DW1903-R2

• Registration Number: NCT05155072
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Primary Completion: 2020-09-07
• Study Completion: 2020-09-07
• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-12-10
• Last Update Submitted: 2021-12-10
• Study First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	DW1903-R2	-
Sequence B	DW1903-R2	-
Sequence E	DW1903-R2	-
Sequence F	DW1903	-
Sequence A	DW1903-R1	-
Sequence B	DW1903-R1	-
Sequence D	DW1903-R2	-
Sequence E	DW1903	-
Sequence A	DW1903	-
Sequence C	DW1903-R2	-
Sequence F	DW1903-R2	-
Sequence C	DW1903	-
Sequence C	DW1903-R1	-
Sequence D	DW1903	-
Sequence F	DW1903-R1	-
Sequence D	DW1903-R1	-
Sequence E	DW1903-R1	-
Sequence B	DW1903	-

Primary Outcome Measures

Name	Time	Method
pH monitoring	up to day 5	Pharmacodynamic Endpoint

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of