A Clinical Trial to Evaluate the Drug-drug Interactions of Co-administered 'HUC2-744-A' and 'HUC2-744-B' in Healthy Adult Volunteers (DDI)

September 6, 2026 updated by: Huons Co., Ltd.

An Open-label, Fixed-sequence, 3-period Clinical Trial to Evaluate the Drug-drug Interactions of Co-administered 'HUC2-744-A' and 'HUC2-744-B' in Healthy Adult Volunteers

This study aims to evaluate the pharmacokinetic interactions between HUC2-744-A and HUC2-744-B following monotherapy or co-administration under multiple-dose conditions.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

For selected subjects, the designated investigational products are administered orally with 200 mL of water during Treatment 1 (HUC2-744-A), Treatment 2 (HUC2-744-B), and Treatment 3 (HUC2-744-A + HUC2-744-B).

Study Type

Interventional

Enrollment (Estimated)

28

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

  • South Korea
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, South Korea, 02841
        • Korea University Anam Hospital
        • Contact:
          • Korea University Anam Hospital
          • Phone Number: +82-02-1577-0083
          • Email: jywon@huons.com

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 adults
  • Subjects with a body weight of 50 kg or more and a BMI within the range of 18.0 to 29.9 kg/m²

Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
  • Presence of acute disease symptoms within 28 days prior to the first dosing
  • History of any disease that may affect drug absorption, distribution, metabolism, or excretion
  • Hypersensitivity or history of clinically significant hypersensitivity to atorvastatin, telmisartan, drugs containing ingredients of the same class, or other medications (e.g., aspirin, antibiotics, dihydropyridine derivatives)

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
IP are administered during Treatment 1 (Atorvastatin), Treatment 2 (Telmisartan), and Treatment 3 (Atorvastatin + Telmisartan)
Drug: Atorvastatin Calcium
HUC2-744-A
Drug: Telmisartan
HUC2-744-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCτ
Time Frame: Day 22
Area Under the Curve of telmisartan, atorvastatin
Day 22
Cmax,ss
Time Frame: Day 22
Maximum concentration at steady state of telmisartan, atorvastatin
Day 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax,ss
Time Frame: Day 22
Maximum concentration at steady state of 2-hydroxy atorvastatin
Day 22
AUCτ
Time Frame: Day 22
Area Under the Curve of 2-hydroxy atorvastatin
Day 22

Collaborators and Investigators

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

Sponsor

Huons Co., Ltd.

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)

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 20, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUC2-744-101

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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