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OpenTrials
Completed

NCT Number: NCT05155072

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

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

Completed

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Key information

Conditions

Gastritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DW1903

Drug

DW1903

DW1903-R1

Drug

DW1903-R1

DW1903-R2

Drug

DW1903-R2

Primary outcomes

  1. pH monitoring

    Time frame: up to day 5

    Pharmacodynamic Endpoint

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2021
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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