A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs

Daewon Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adult

Treatments: Drug: DW4421-N2; Drug: DW4421; Drug: DW4421-N3; Drug: DW4421-N1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07343245

DW4421-102

Details and patient eligibility

About

Drug-Drug Interaction between DW4421 and three different kinds of NSAIDs

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
• Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion criteria

• Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 6 patient groups

Cohort 1, A

Experimental group

Treatment:

Drug: DW4421-N1

Drug: DW4421

Cohort 1, B

Experimental group

Treatment:

Drug: DW4421-N1

Drug: DW4421

Cohort 2, C

Experimental group

Treatment:

Drug: DW4421

Drug: DW4421-N2

Cohort 2, D

Experimental group

Treatment:

Drug: DW4421

Drug: DW4421-N2

Cohort 3, E

Experimental group

Treatment:

Drug: DW4421-N3

Drug: DW4421

Cohort 3, F

Experimental group

Treatment:

Drug: DW4421-N3

Drug: DW4421