Peripheral Arterial DiseasePhase 1NCT07901088
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
A Phase 1 study testing Test Drug and Reference Drug in people with Peripheral Arterial Disease, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the bioequivalence and safety of AJU-B718 and B718R in Healthy Adults. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Test Drug and Reference Drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2026to Dec 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 19 to less than 65 years at screening.
- Healthy adults without clinically significant congenital or chronic diseases.
- Considered eligible based on screening test results.
- BMI 18 to 30 kg/m², with body weight ≥50 kg for males and ≥45 kg for females.
- Provided written informed consent.
- Willing to comply with the specified contraception and reproductive restrictions.
Who cannot join
- Use of prohibited or potentially interfering medications within the specified period prior to the first administration.
- Excessive alcohol consumption within 1 month prior to the first administration.
- Participation in another clinical trial involving administration of an investigational product within 6 months prior to the first administration.
- Blood donation within the specified period prior to the first administration.
- History of gastrointestinal surgery that may affect drug absorption.
- Clinically significant bleeding disorders or other medical conditions that may affect study participation.
Show all 9Show fewer
- History of clinically significant psychiatric disorders.
- Considered unsuitable for study participation by the Investigator or delegated physician.
- Pregnancy, suspected pregnancy, or breastfeeding in female participants.
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
H+ Yangji Hospital
Seoul, Seoul
Heejoo, Hong, +82-1877-8875, m4688@newyjh.com
About this study
Official title: A Randomized, Open-Label, Fasting, Single-Dose, Oral, 2-Group, 4-Period, Replicate Crossover Study to Evaluate the Bioequivalence and Safety of AJU-B718 and B718R in Healthy Adult Volunteers
To evaluate the bioequivalence and safety of AJU-B718 and B718R in Healthy Adults.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Test Drug, Reference Drug
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test DrugDrug
AJU-B718
Reference DrugDrug
B718R
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: Reference Drug, Single dose / Period 2: Test Drug, Single dose / Period 3: Reference Drug, Single dose / Period 4: 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 / Period 3: Test Drug, Single dose / Period 4: 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-B718
Measured: Pre-dose(0 hours) ~ 24 hours
Cmax of AJU-B718
Measured: Pre-dose(0 hours) ~ 24 hours
Secondary outcomes (4)
AUCinf of AJU-B718
Measured: Pre-dose(0 hours) ~ 24 hours
Tmax of AJU-B718
Measured: Pre-dose(0 hours) ~ 24 hours
t1/2 of AJU-B718
Measured: Pre-dose(0 hours) ~ 24 hours
AUCt/AUCinf of AJU-B718
Measured: Pre-dose(0 hours) ~ 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- 40 participants (estimated)
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
- NCT07901088
- Sponsor's protocol ID
- 26CAO12101
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Fasting, Single-Dose, Oral, 2-Group, 4-Period, Replicate Crossover Study to Evaluate the Bioequivalence and Safety of AJU-B718 and B718R in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07901088
- Acronym / sponsor ID
- 26CAO12101
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Oct 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.
To evaluate the bioequivalence and safety of AJU-B718 and B718R 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 / Period 3: Reference Drug, Single dose / Period 4: Test Drug, Single dose |
| Sequence B | Experimental | Drug: Test Drug, Drug: Reference DrugPeriod 1: Test Drug, Single dose / Period 2: Reference Drug, Single dose / Period 3: Test Drug, Single dose / Period 4: Reference Drug, Single dose |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 19 to less than 65 years at screening.
- Healthy adults without clinically significant congenital or chronic diseases.
- Considered eligible based on screening test results.
- BMI 18 to 30 kg/m², with body weight ≥50 kg for males and ≥45 kg for females.
- Provided written informed consent.
Key exclusion criteria (9 listed)
- Use of prohibited or potentially interfering medications within the specified period prior to the first administration.
- Excessive alcohol consumption within 1 month prior to the first administration.
- Participation in another clinical trial involving administration of an investigational product within 6 months prior to the first administration.
- Blood donation within the specified period prior to the first administration.
- History of gastrointestinal surgery that may affect drug absorption.
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-B718 | Drug | Sequence A, Sequence B |
| Reference DrugB718R | Drug | Sequence A, Sequence B |
Primary outcome
AUCt of AJU-B718
Time frame: Pre-dose(0 hours) ~ 24 hours
Cmax of AJU-B718
Time frame: Pre-dose(0 hours) ~ 24 hours
4 secondary outcomes
AUCinf of AJU-B718
Time frame: Pre-dose(0 hours) ~ 24 hours
Tmax of AJU-B718
Time frame: Pre-dose(0 hours) ~ 24 hours
t1/2 of AJU-B718
Time frame: Pre-dose(0 hours) ~ 24 hours
AUCt/AUCinf of AJU-B718
Time frame: Pre-dose(0 hours) ~ 24 hours
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 28 Oct 2026.
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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.
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 Peripheral Arterial Disease, 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 6 inclusion and 9 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 28 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCt of AJU-B718 (time frame: Pre-dose(0 hours) ~ 24 hours). 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 28 Oct 2026.