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A Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-231A and AD-231B and AD-231C

NCT ID: NCT07312773

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-23

Study Completion Date

2026-02-22

Brief Summary

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To evaluate the pharmacokinetic interactions of AD-231A, AD-231B, and AD-231C in healthy adult volunteers.

Detailed Description

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Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Period 1 : Treatment A(AD-231A), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C)

Group Type EXPERIMENTAL

Treatment A(AD-231A)

Intervention Type DRUG

AD-231A Oral Tablet

Treatment C(AD-231A+AD-231B+AD-231C)

Intervention Type DRUG

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

Arm B

Period 1 : Treatment B(AD-231B+AD-231C), Period 2 : Treatment C(AD-231A+AD-231B+AD-231C)

Group Type EXPERIMENTAL

Treatment B(AD-231B+AD-231C)

Intervention Type DRUG

AD-231B+AD-231C Oral Tablet

Treatment C(AD-231A+AD-231B+AD-231C)

Intervention Type DRUG

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

Interventions

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Treatment A(AD-231A)

AD-231A Oral Tablet

Intervention Type DRUG

Treatment B(AD-231B+AD-231C)

AD-231B+AD-231C Oral Tablet

Intervention Type DRUG

Treatment C(AD-231A+AD-231B+AD-231C)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult volunteers aged ≥19 and \<65 years at the time of the screening visit
* Body weight ≥50 kg (≥45 kg for females) and body mass index (BMI) between 18.0 kg/m² and 30.0 kg/m² at the time of the screening visit

Exclusion Criteria

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

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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H+ Yangji Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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JaeHun Jung

Role: CONTACT

Phone: +8247679615

Email: [email protected]

Other Identifiers

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AD-231DDI

Identifier Type: -

Identifier Source: org_study_id