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

Phase 1

Recruiting

• Conditions: Primary Hypertension
• Interventions: Drug: Co-administration of AD-227A and AD-227B; Drug: Administration of AD-227

• Registration Number: NCT06884085
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-18
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A (RT)	Co-administration of AD-227A and AD-227B	Period 1: Reference (Co-administration of AD-227A and AD-227B), Period 2: Test (AD-227)
Sequence A (RT)	Administration of AD-227	Period 1: Reference (Co-administration of AD-227A and AD-227B), Period 2: Test (AD-227)
Sequene B (TR)	Co-administration of AD-227A and AD-227B	Period 1: Test (AD-227), Period 2: Reference (Co-administration of AD-227A and AD-227B)
Sequene B (TR)	Administration of AD-227	Period 1: Test (AD-227), Period 2: Reference (Co-administration of AD-227A and AD-227B)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Central Hospital; 🇰🇷 Seoul, Korea, Republic of