Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin

Phase 1Not Yet RecruitingNCT07382661

Daewon Pharmaceutical Co., Ltd.36 enrolled

Overview

Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Adult Volunteers

Interventions

DW4421DRUG

1 tablet will be orally administered

DW4421-1DRUG

2 capsules will be orally administered

DW4421-2DRUG

1 tablet will be orally administered

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * 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, North Chungcheong, South Korea

Outcomes

Primary Outcomes

Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state

Time frame: Up to day 6 or day 7

AUCτ,ss: Area under the drug concentration-time curve of DW4421, DW4421-1, DW4421-2 within a dosing interval at steady state

Time frame: Up to day 6 or day 7

Data from ClinicalTrials.gov

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