Evaluate the Pharmacokinetic Interaction and the Safety of AD-2321 and AD-2322

December 17, 2025 updated by: Addpharma Inc.

A Two-arm, Open-label, Single-sequence, Multiple-dose Study to Evaluate the Pharmacokinetic Interaction and the Safety of AD-2321 and AD-2322 in Healthy Adult Volunteers

To evaluate the pharmacokinetic interactions of AD-2321, AD-2322 in healthy adult volunteers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Period 1 : Treatment A(AD-2321), Period 2 : Treatment C(AD-2321+AD-2322)
Drug: Treatment A(AD-2321)
AD-2321 Oral Tablet
Drug: Treatment C(AD-2321+AD-2322)
AD-2321 Oral Tablet+AD-2322 Oral Tablet
Experimental: Arm B
Period 1 : Treatment B(AD-2322), Period 2 : Treatment C(AD-2321+AD-2322)
Drug: Treatment C(AD-2321+AD-2322)
AD-2321 Oral Tablet+AD-2322 Oral Tablet
Drug: Treatment B(AD-2322)
AD-2322 Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration-time curve during dosing interval at steady state (AUCτ,ss)
Time Frame: pre-dose (0hour) to 24 hours post-dose on Day 14
AUCτ,ss
pre-dose (0hour) to 24 hours post-dose on Day 14
Maximum concentration of drug in plasma at steady state (Cmax,ss)
Time Frame: pre-dose (0hour) to 24 hours post-dose on Day 14
pre-dose (0hour) to 24 hours post-dose on Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 27, 2026

Primary Completion (Estimated)

February 11, 2026

Study Completion (Estimated)

February 26, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-232DDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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