Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)

Dong-A ST Co., Ltd.30 enrolled

Overview

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DA-2811DRUG

single dose administration (one tablet once a day)

DA-2811-RDRUG

single dose administration (one tablet once a day)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and/or female subjects * BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg * Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress Exclusion Criteria: * Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease

Locations (1)

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, South Korea

Outcomes

Primary Outcomes

AUClast

Area under the plasma concentration-time curve from time zero to time the last quantifiable time

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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