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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06884085

Enrollment

Registered

2025-03-19

Start date

2025-07-12

Completion date

2025-08-13

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypertension

Brief summary

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

Interventions

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

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

DRUGAdministration of AD-227

Administration of AD-227 1Tab., Per Oral

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026