HypercholesterolemiaPhase 1NCT06931327
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C711 in Healthy Adults
A Phase 1 study testing Test Drug and Reference Drug in people with Hypercholesterolemia, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the safety and pharmacokinetic characteristics of AJU-C711 in healthy adults Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Test Drug and Reference Drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2025to 18 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers aged ≥ 19-year-old
- Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
- Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
- 6. Those who agree to contraception during the participation of clinical trial 7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Who cannot join
- Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days
- Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study
- Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug
- Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, liquor: 30mL or Beer 250mL)
- Those who has under
Show all 16Show fewer
- Those who are hypersensitive to component of the Investigational product and have the medical history
- Those with active liver disease or persistent elevation of aminotransferase levels of unknown
- Those with severe hepatic impairment or biliary atresia and cholestasis
- Those taking cyclosporin
- Those with myopathy
- Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
- Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- Those who has a history of mental illness
- Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons
- Women who are pregnant or who may be pregnant and breastfeed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate Bioequivalence of AJU-C711 Compared to C711R in Healthy Adult Volunteers
To evaluate the safety and pharmacokinetic characteristics of AJU-C711 in healthy adults
- Conditions
- Hypercholesterolemia
- Being tested
- Test Drug, Reference Drug
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test DrugDrug
AJU-C711
Reference DrugDrug
C711R
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: Reference Drug, single dose Period 2: Test Drug, single dose Receives: Drug: Test Drug; Drug: Reference Drug |
| Sequence B | Experimental | Period 1: Test Drug, single dose Period 2: Reference Drug, single dose Receives: Drug: Test Drug; Drug: Reference Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of AJU-C711
Measured: Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr
Cmax of AJU-C711
Measured: Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start29 Mar 2025
- Primary completion16 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931327
- Sponsor's protocol ID
- 24PHL11501
- Status last verified
- Jun 2025
- First submitted
- 9 Apr 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single Dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate Bioequivalence of AJU-C711 Compared to C711R in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06931327
- Acronym / sponsor ID
- 24PHL11501
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 17 Apr 2025 (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.
To evaluate the safety and pharmacokinetic characteristics of AJU-C711 in healthy adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Test Drug, Drug: Reference DrugPeriod 1: Reference Drug, single dose Period 2: Test Drug, single dose |
| Sequence B | Experimental | Drug: Test Drug, Drug: Reference DrugPeriod 1: Test Drug, single dose Period 2: Reference Drug, single dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult volunteers aged ≥ 19-year-old
- Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
- Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
- 6. Those who agree to contraception during the participation of clinical trial 7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
Key exclusion criteria (16 listed)
- Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
- Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days
- Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study
- Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug
- Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, liquor: 30mL or Beer 250mL)
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 |
|---|---|---|
| Test DrugAJU-C711 | Drug | Sequence A, Sequence B |
| Reference DrugC711R | Drug | Sequence A, Sequence B |
Primary outcome
AUCt of AJU-C711
Time frame: Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr
Cmax of AJU-C711
Time frame: Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Test Drug and Reference Drug in people with Hypercholesterolemia, run by AJU Pharm 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 12 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of AJU-C711 (time frame: Pre-dose (0 hr) 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hr). 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 12 Jun 2025.