A Study to Compare to PK Characteristics and Safety Profiles Between AD-227 and Co-administration of AD-227A and AD-227B

NCT ID: NCT06884085

Last Updated: 2025-12-01

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-12

Study Completion Date

2025-08-13

Brief Summary

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Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-227 in healthy subjects.

Detailed Description

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Conditions

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Primary Hypertension

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 (RT)

Period 1: Reference (Co-administration of AD-227A and AD-227B), Period 2: Test (AD-227)

Group Type EXPERIMENTAL

Co-administration of AD-227A and AD-227B

Intervention Type DRUG

Co-administration of AD-227A 1Tab. and AD-227B 1Tab., Per Oral

Administration of AD-227

Intervention Type DRUG

Administration of AD-227 1Tab., Per Oral

Sequene B (TR)

Period 1: Test (AD-227), Period 2: Reference (Co-administration of AD-227A and AD-227B)

Group Type EXPERIMENTAL

Co-administration of AD-227A and AD-227B

Intervention Type DRUG

Co-administration of AD-227A 1Tab. and AD-227B 1Tab., Per Oral

Administration of AD-227

Intervention Type DRUG

Administration of AD-227 1Tab., Per Oral

Interventions

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Co-administration of AD-227A and AD-227B

Co-administration of AD-227A 1Tab. and AD-227B 1Tab., Per Oral

Intervention Type DRUG

Administration of AD-227

Administration of AD-227 1Tab., Per Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight equal to or greater than 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied
Minimum Eligible Age

19 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

Locations

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Central Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-227BE-02

Identifier Type: -

Identifier Source: org_study_id

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