Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State

Dong-A ST Co., Ltd.40 enrolled

Overview

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01 (5/1000 mg x1 tablets) at fasting state.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DA-1229_01 5/1000mg (Before)DRUG

single dose administration (one tablet once a day)

DA-1229_01 5/1000mg (After)DRUG

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)

Metro Hospital

Anyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

AUCt

area under the curve

Time frame: pre-dose~96 hours post-dose

Cmax

maximum plasma concentration

Time frame: pre-dose~96 hours post-dose

Data from ClinicalTrials.gov

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