Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fasting State

Phase 1CompletedNCT05098262

Dong-A ST Co., Ltd.40 enrolled

Overview

Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy subjects at Fasting State

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DA-5210 10/500mgDRUG

single dose administration (one tablet once a day)

DA-5210-R 10/500mgDRUG

single dose administration (one tablet once a day)

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Volunteers * BMI between 18 and 30 kg/m2 * Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: * Allergy or Drug hypersensitivity * Clinically significant Medical History

Locations (1)

H Plus Yangji Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUCt

area under the curve

Time frame: pre-dose~48 hours post-dose

Cmax

maximum plasma concentration

Time frame: pre-dose~48 hours post-dose

Data from ClinicalTrials.gov

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