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Pharmacokinetics and Safety Profiles After Administration of DA-5218 and Co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in Healthy Adult Volunteers

NCT ID: NCT05449704

Last Updated: 2022-07-08

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2022-09-07

Brief Summary

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Pharmacokinetics and safety Profiles after administration of DA-5218 and co-administration of DA-5218-R1, DA-5218-R2 and DA-5218-R3 in healthy adult volunteers

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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 A

Group Type EXPERIMENTAL

DA-5218

Intervention Type DRUG

single dose administration (DA-5218 one tablet once a day)

DA-5218-R1 + DA-5218-R2 + DA-5218-R3

Intervention Type DRUG

single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-R3 one tablet once a day)

Sequence B

Group Type EXPERIMENTAL

DA-5218

Intervention Type DRUG

single dose administration (DA-5218 one tablet once a day)

DA-5218-R1 + DA-5218-R2 + DA-5218-R3

Intervention Type DRUG

single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-R3 one tablet once a day)

Interventions

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DA-5218

single dose administration (DA-5218 one tablet once a day)

Intervention Type DRUG

DA-5218-R1 + DA-5218-R2 + DA-5218-R3

single dose administration (DA-5218-R1 one tablet once a day + DA-5218-R2 one tablet once a day + DA-5218-R3 one tablet once a day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria

* Subjects with allergy or drug hypersensitivity
* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted
Minimum Eligible Age

19 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

Locations

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Bumin Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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JiHyun Sung

Role: CONTACT

[email protected]
+82-2-920-8369

Facility Contacts

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TaeGon Hong, Ph.D

Role: primary

[email protected]

Other Identifiers

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DA5218_BE_I

Identifier Type: -

Identifier Source: org_study_id

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