Study to Evaluate the Effect of Food on the Pharmacokinetics and Pharmacodynamics Characteristics in Healthy Adult Volunteers

Phase 1CompletedNCT07364838

Daewon Pharmaceutical Co., Ltd.24 enrolled

Overview

A Randomized, Open-label, Oral in healthy volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

GERD (Gastroesophageal Reflux Disease)

Interventions

DW4421DRUG

DW4421 on fasted or fed condition

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Volunteers who are ≥19 years old * Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 Exclusion Criteria: * Clinically significant Medical History * In the case of women, pregnant(Urine-HCG positive) or lactating women

Locations (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Cmax of DW4421

Time frame: up to 48 hours

Area under the plasma concentration versus time curve (AUC)

AUC of DW4421

Time frame: up to 48 hours

Data from ClinicalTrials.gov

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