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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07784608
Acronym
DDI
Enrollment
28
Registered
2026-08-25
Start date
2026-09-01
Completion date
2027-11-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-drug Interactions

Keywords

Drug-Drug Interactions

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.

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).

Interventions

DRUGAtorvastatin Calcium

HUC2-744-A

DRUGTelmisartan

HUC2-744-B

Sponsors

Huons Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
AUCτDay 22Area Under the Curve of telmisartan, atorvastatin
Cmax,ssDay 22Maximum concentration at steady state of telmisartan, atorvastatin

Secondary

MeasureTime frameDescription
Cmax,ssDay 22Maximum concentration at steady state of 2-hydroxy atorvastatin
AUCτDay 22Area Under the Curve of 2-hydroxy atorvastatin

Countries

South Korea

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026