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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Primary Hypertension

Treatments: Drug: Administration of AD-227; Drug: Co-administration of AD-227A and AD-227B

Study type: Interventional

Funder types: Industry

Identifiers

NCT06884085

AD-227BE-02

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Sequence A (RT)

Experimental group

Description:

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

Treatment:

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

Drug: Administration of AD-227

Sequene B (TR)

Experimental group

Description:

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

Treatment:

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

Drug: Administration of AD-227