Primary HypertensionPhase 1NCT06884085

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

A Phase 1 study testing Co-administration of AD-227A and AD-227B and Administration of AD-227 in people with Primary Hypertension, run by Addpharma Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Primary Hypertension
What is being tested?: Co-administration of AD-227A and AD-227B and Administration of AD-227
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteSouth Korea
Study dates: 12 Jul 2025to 13 Aug 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Central Hospital
Seoul

Other trials in South Korea

About this study

Official title: 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.

Conditions: Primary Hypertension
Being tested: Co-administration of AD-227A and AD-227B, Administration of AD-227
Medical subject headings: Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06884085
Study group	Role	What they receive
Sequence A (RT)	Experimental	Period 1: Reference (Co-administration of AD-227A and AD-227B), Period 2: Test (AD-227) Receives: Drug: Co-administration of AD-227A and AD-227B; Drug: Administration of AD-227
Sequene B (TR)	Experimental	Period 1: Test (AD-227), Period 2: Reference (Co-administration of AD-227A and AD-227B) Receives: Drug: Co-administration of AD-227A and AD-227B; Drug: Administration of AD-227

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 202513 Aug 2025

First posted19 Mar 2025
Study start12 Jul 2025
Primary completion13 Aug 2025
Study completion13 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06884085
Sponsor's protocol ID: AD-227BE-02
Status last verified: Nov 2025
First submitted: 13 Mar 2025
Last updated: 1 Dec 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Primary Aldosteronism, Hypertension
Enrolling by invitationPhase 3
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
PAH, Pulmonary Hypertension
Recruiting
The REACH-OUT Trial
Hypertension, Reproductive Behavior
Not yet recruiting
Sacubitril/Valsartan Versus Valsartan Alone on Left Atrial Volume Index in Hypertensive Patients
Hypertension, Left Ventricular Diastolic Dysfunction
RecruitingPhase 4
Effect of the Traditional Chinese Medicine Yufeng Ningxin in Patients With Hypertension
Hypertension, Essential (Primary) Hypertension

All Primary Hypertension trials