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

Phase 1RecruitingNCT07343245

Daewon Pharmaceutical Co., Ltd.150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

150

Conditions

Healthy Adult

Interventions

DW4421DRUG

DW4421-N1DRUG

BID

DW4421-N2DRUG

BID

DW4421-N3DRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

RECRUITING

Outcomes

Primary Outcomes

Cmax,ss

Time frame: Baseline to Day 13 or Day 15

AUCτ,ss

Time frame: Baseline to Day 13 or Day 15

Data from ClinicalTrials.gov

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