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
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