NCT07590167

Brief Summary

A Study to Evaluate the Safety and Pharmacokinetics of AD-231 Compared to Coadministration of AD-231A, AD-231D and AD-231C

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
1mo left

Started Jun 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

DyslipidemiaHypertension

Outcome Measures

Primary Outcomes (2)

  • Maximum concentration of drug in plasma (Cmax)

    Cmax

    pre-dose to 72 hours

  • Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt

    pre-dose to 72 hours

Study Arms (2)

Sequence A (RT)

EXPERIMENTAL

Period 1: Reference Drug(AD-231A, AD-231D and AD-231C), Period 2 : Test Drug(AD-231)

Drug: AD-231Drug: AD-231A, AD-231D and AD-231C

Sequence B (TR)

EXPERIMENTAL

Period 1: Test Drug(AD-231), Period 2 : Reference Drug(AD-231A, AD-231D and AD-231C)

Drug: AD-231Drug: AD-231A, AD-231D and AD-231C

Interventions

AD-231DRUG

AD-231 Oral Tablet

Sequence A (RT)Sequence B (TR)
AD-231A, AD-231D and AD-231CDRUG

AD-231A Oral Tablet + AD-231D Oral Tablet + AD-231C Oral Tablet

Sequence A (RT)Sequence B (TR)

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 and under 65 years in healthy volunteers at the time of screening visit

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospita

Seoul, South Korea

Location

MeSH Terms

Conditions

DyslipidemiasHypertension

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Dasom KIM

CONTACT

+82-31-891-5572dskim@addpharma.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 15, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)