A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole

NCT ID: NCT04494243

Last Updated: 2021-07-21

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2021-01-15

Brief Summary

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A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.

Detailed Description

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This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 10/600mg compared with administration of Rabeprazole 10mg in healthy volunteers.

Conditions

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Gastroesophageal Reflux Disease

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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AD-214/Rabeprazole

Period 1 : Test Drug(AD-214 10/600mg) Period 2 : Reference Drug(Rabeprazole 10mg)

Group Type EXPERIMENTAL

AD-214 10/600mg

Intervention Type DRUG

1 tablet administered before the breakfast during 7 days

Rabeprazole 10mg

Intervention Type DRUG

1 tablet administered before the breakfast during 7 days

Rabeprazole/AD-214

Period 1 : Reference Drug(Rabeprazole 10mg) Period 2 : Test Drug(AD-214 10/600mg)

Group Type EXPERIMENTAL

AD-214 10/600mg

Intervention Type DRUG

1 tablet administered before the breakfast during 7 days

Rabeprazole 10mg

Intervention Type DRUG

1 tablet administered before the breakfast during 7 days

Interventions

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AD-214 10/600mg

1 tablet administered before the breakfast during 7 days

Intervention Type DRUG

Rabeprazole 10mg

1 tablet administered before the breakfast during 7 days

Intervention Type DRUG

Other Intervention Names

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Test drug Reference Drug

Eligibility Criteria

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Inclusion Criteria

* Age 19\~50 years in healthy volunteers
* BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seunghwan Lee, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-214PK/PD

Identifier Type: -

Identifier Source: org_study_id

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