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

NCT ID: NCT04938752

Last Updated: 2022-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-08

Study Completion Date

2021-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence I

Group Type EXPERIMENTAL

DA-2811

Intervention Type DRUG

single dose administration (one tablet once a day)

DA-2811-R

Intervention Type DRUG

single dose administration (one tablet once a day)

Sequence II

Group Type EXPERIMENTAL

DA-2811

Intervention Type DRUG

single dose administration (one tablet once a day)

DA-2811-R

Intervention Type DRUG

single dose administration (one tablet once a day)

Interventions

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DA-2811

single dose administration (one tablet once a day)

Intervention Type DRUG

DA-2811-R

single dose administration (one tablet once a day)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chung JaeYong

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA2811_BE2_I

Identifier Type: -

Identifier Source: org_study_id

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