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

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Gastritis

Treatments: Drug: DW1903-R2; Drug: DW1903-R1; Drug: DW1903

Study type: Interventional

Funder types: Industry

Identifiers

NCT05155072

DW1903-101D

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 6 patient groups

Sequence A

Experimental group

Treatment:

Drug: DW1903

Drug: DW1903-R2

Drug: DW1903-R1

Sequence B

Experimental group

Treatment:

Drug: DW1903

Drug: DW1903-R2

Drug: DW1903-R1

Sequence C

Experimental group

Treatment:

Drug: DW1903

Drug: DW1903-R2

Drug: DW1903-R1

Sequence D

Experimental group

Treatment:

Drug: DW1903

Drug: DW1903-R2

Drug: DW1903-R1

Sequence E

Experimental group

Treatment:

Drug: DW1903

Drug: DW1903-R2

Drug: DW1903-R1

Sequence F

Experimental group

Treatment:

Drug: DW1903

Drug: DW1903-R2

Drug: DW1903-R1