Drug-drug InteractionsPhase 1DDINCT07784608
A Clinical Trial to Evaluate the Drug-drug Interactions of Co-administered 'HUC2-744-A' and 'HUC2-744-B' in Healthy Adult Volunteers
A Phase 1 study testing Atorvastatin Calcium and Telmisartan in people with Drug-drug Interactions, run by Huons Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interactions
- What is being tested?
- Atorvastatin Calcium and Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2026to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
Korea University Anam Hospital, +82-02-1577-0083, jywon@huons.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Drug-drug Interactions
- Being tested
- Atorvastatin Calcium, Telmisartan
- Keywords
- Drug-Drug Interactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin CalciumDrug
HUC2-744-A
TelmisartanDrug
HUC2-744-B
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | IP are administered during Treatment 1 (Atorvastatin), Treatment 2 (Telmisartan), and Treatment 3 (Atorvastatin + Telmisartan) Receives: Drug: Atorvastatin Calcium; Drug: Telmisartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ
Area Under the Curve of telmisartan, atorvastatin
Measured: Day 22
Cmax,ss
Maximum concentration at steady state of telmisartan, atorvastatin
Measured: Day 22
Secondary outcomes (2)
Cmax,ss
Maximum concentration at steady state of 2-hydroxy atorvastatin
Measured: Day 22
AUCτ
Area Under the Curve of 2-hydroxy atorvastatin
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784608
- Sponsor's protocol ID
- HUC2-744-101
- Acronym
- DDI
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07784608
- Acronym / sponsor ID
- DDI / HUC2-744-101
- Conditions
- Drug-drug Interactions
- Keywords
- Drug-Drug Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Atorvastatin Calcium, Drug: TelmisartanIP are administered during Treatment 1 (Atorvastatin), Treatment 2 (Telmisartan), and Treatment 3 (Atorvastatin + Telmisartan) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin CalciumHUC2-744-A | Drug | single arm |
| TelmisartanHUC2-744-B | Drug | single arm |
Primary outcome
AUCτ
Time frame: Day 22
Area Under the Curve of telmisartan, atorvastatin
Cmax,ss
Time frame: Day 22
Maximum concentration at steady state of telmisartan, atorvastatin
2 secondary outcomes
Cmax,ss
Time frame: Day 22
AUCτ
Time frame: Day 22
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Related trials for Drug-drug Interactions
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Healthy
Not yet recruitingPhase 1
LTG-321 - Itraconazole Drug-drug Interaction (DDI) Study
PK Drug-drug Interaction Study
Active, not recruitingPhase 1
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin Calcium and Telmisartan in people with Drug-drug Interactions, run by Huons Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huons (+82-70-7492-6023, jywon@huons.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCτ (time frame: Day 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.