Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of DW1903
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
1 other identifier
interventional
31
1 country
1
Brief Summary
A Randomized, Open-label, Oral in healthy male volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2020
CompletedFirst Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedDecember 13, 2021
October 1, 2021
4 months
October 28, 2021
December 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
pH monitoring
Pharmacodynamic Endpoint
up to day 5
Study Arms (6)
Sequence A
EXPERIMENTALSequence B
EXPERIMENTALSequence C
EXPERIMENTALSequence D
EXPERIMENTALSequence E
EXPERIMENTALSequence F
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy Volunteers who are ≥19 years old
- BMI between 18 and 30 kg/m2
- Body weight ≥50kg
You may not qualify if:
- Clinically significant Medical History
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungbuk National University Hospital
Cheongju-si, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
December 13, 2021
Study Start
May 15, 2020
Primary Completion
September 7, 2020
Study Completion
September 7, 2020
Last Updated
December 13, 2021
Record last verified: 2021-10