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

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-227 Compared to Co-administration of AD-227A and AD-227B in Healthy Adult Volunteers Under Fasting Conditions

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

Study Overview

• Status: Completed
• Conditions: Primary Hypertension
• Intervention / Treatment: Drug: Co-administration of AD-227A and AD-227B; Drug: Administration of AD-227

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A (RT); Period 1: Reference (Co-administration of AD-227A and AD-227B), Period 2: Test (AD-227)	Drug: Co-administration of AD-227A and AD-227B; Co-administration of AD-227A 1Tab. and AD-227B 1Tab., Per Oral; Drug: Administration of AD-227; Administration of AD-227 1Tab., Per Oral
Experimental: Sequene B (TR); Period 1: Test (AD-227), Period 2: Reference (Co-administration of AD-227A and AD-227B)	Drug: Co-administration of AD-227A and AD-227B; Co-administration of AD-227A 1Tab. and AD-227B 1Tab., Per Oral; Drug: Administration of AD-227; Administration of AD-227 1Tab., Per Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration of drug in plasma (Cmax)	Cmax of AD-227	pre-dose (0hour) to 72hours
Area under the plasma concentration-time curve during dosing interval (AUCt)	AUCt of AD-227	pre-dose (0hour) to 72hours

Collaborators and Investigators

• Sponsor: Addpharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2025
• Primary Completion (Actual): August 13, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: AD-227BE-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No