NCT07784608

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
14mo left

Started Sep 2026

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

August 25, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

August 5, 2026

Last Update Submit

August 20, 2026

Conditions

Drug-drug Interactions

Keywords

Drug-Drug Interactions

Outcome Measures

Primary Outcomes (2)

  • AUCτ

    Area Under the Curve of telmisartan, atorvastatin

    Day 22

  • Cmax,ss

    Maximum concentration at steady state of telmisartan, atorvastatin

    Day 22

Secondary Outcomes (2)

  • Cmax,ss

    Day 22

  • AUCτ

    Day 22

Study Arms (1)

single arm

EXPERIMENTAL

IP are administered during Treatment 1 (HUC2-744-A), Treatment 2 (HUC2-744-B), and Treatment 3 (HUC2-744-A + HUC2-744-B)

Drug: Atorvastatin CalciumDrug: Telmisartan

Interventions

Atorvastatin CalciumDRUG

HUC2-744-A

single arm
TelmisartanDRUG

HUC2-744-B

single arm

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

MeSH Terms

Interventions

AtorvastatinTelmisartan

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Huons

CONTACT

+82-70-7492-6023jywon@huons.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 25, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-07

Locations

KR(1)