Bronchial AsthmaPhase 1NCT07231861
Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
A Phase 1 study testing AJU-R713 and R713R in people with Bronchial Asthma and Perennial Allergic Rhinitis, run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate 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
- Bronchial Asthma, Perennial Allergic Rhinitis
- What is being tested?
- AJU-R713 and R713R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2025to 7 Jan 2026
- 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 adults aged 19 years or older at the time of screening.
- Body mass index (BMI) between 18 and 30 kg/m².
- Male subjects: body weight ≥ 50 kg.
- Female subjects: body weight ≥ 45 kg.
- Clinically healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, as determined by the investigator.
- Willing and able to provide written informed consent after receiving a full explanation of the study.
- Subjects (and their partners, if applicable) agree to use highly effective, non-hormonal contraception from the first dosing day until one week after the last dose.
Who cannot join
- Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
- Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
- Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
- History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
- Known hypersensitivity to the investigational product or its components.
- Known metabolic or genetic disorders such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or phenylketonuria.
- History of clinically significant psychiatric illness.
- Pregnant or breastfeeding women, or women with a possibility of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-R713" and "R713R" in Healthy Adult Volunteers
To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
Read the detailed description
This study evaluates the pharmacokinetic characteristics and safety of pranlukast in healthy adults. It is a randomized, open-label, single-dose, two-period crossover trial conducted under fasting conditions. Pharmacokinetic samples are collected up to 24 hours after dosing, and standard safety assessments are performed throughout the study.
- Conditions
- Bronchial Asthma, Perennial Allergic Rhinitis
- Being tested
- AJU-R713, R713R
- Medical subject headings
- Asthma, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AJU-R713Drug
Oral formulation
R713RDrug
Oral formulation
| Study group | Role | What they receive |
|---|---|---|
| Pranlukast Test Formulation | Experimental | Two-period, single-dose, crossover study Receives: Drug: AJU-R713; Drug: R713R |
| Pranlukast Reference Formulation | Experimental | Two-period, single-dose, crossover study (reversed order) Receives: Drug: AJU-R713; Drug: R713R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Pranlukast
To assess the maximum observed plasma concentration (Cmax) of Pranlukast
Measured: 0 hour ~ 24 hour after drug administration
AUCt of Pranlukast
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast
Measured: 0 hour ~ 24 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start12 Dec 2025
- Primary completion21 Dec 2025
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies 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
- 62 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
- NCT07231861
- Sponsor's protocol ID
- 25BA11701
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-R713" and "R713R" in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07231861
- Acronym / sponsor ID
- 25BA11701
- Conditions
- Bronchial Asthma, Perennial Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 17 Nov 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 Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
Detailed description
This study evaluates the pharmacokinetic characteristics and safety of pranlukast in healthy adults. It is a randomized, open-label, single-dose, two-period crossover trial conducted under fasting conditions. Pharmacokinetic samples are collected up to 24 hours after dosing, and standard safety assessments are performed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pranlukast Test Formulation | Experimental | Drug: AJU-R713, Drug: R713RTwo-period, single-dose, crossover study |
| Pranlukast Reference Formulation | Experimental | Drug: AJU-R713, Drug: R713RTwo-period, single-dose, crossover study (reversed order) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adults aged 19 years or older at the time of screening.
- Body mass index (BMI) between 18 and 30 kg/m².
- Clinically healthy based on medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, as determined by the investigator.
- Willing and able to provide written informed consent after receiving a full explanation of the study.
- Subjects (and their partners, if applicable) agree to use highly effective, non-hormonal contraception from the first dosing day until one week after the last dose.
Key exclusion criteria (8 listed)
- Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
- Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
- Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
- History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
- Known hypersensitivity to the investigational product or its components.
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 |
|---|---|---|
| AJU-R713Oral formulation | Drug | Pranlukast Reference Formulation, Pranlukast Test Formulation |
| R713ROral formulation | Drug | Pranlukast Reference Formulation, Pranlukast Test Formulation |
Primary outcome
Cmax of Pranlukast
Time frame: 0 hour ~ 24 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Pranlukast
AUCt of Pranlukast
Time frame: 0 hour ~ 24 hour after drug administration
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Pranlukast
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 18 Sep 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. 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 AJU-R713 and R713R in people with Bronchial Asthma and Perennial Allergic Rhinitis, 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 7 inclusion and 8 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 18 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?
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?
Cmax of Pranlukast (time frame: 0 hour ~ 24 hour after drug administration). 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 18 Sep 2026.