Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AJU-R713, R713R.
- Who it may be relevant to
- Registry conditions: Bronchial Asthma, Perennial Allergic Rhinitis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug AJU-R713
Oral formulation - Drug R713R
Oral formulation
Primary outcome measures
- Cmax of Pranlukast [Time frame: 0 hour ~ 24 hour after drug administration]
- AUCt of Pranlukast [Time frame: 0 hour ~ 24 hour after drug administration]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- H Plus Yangji Hospital — Seoul
Identifiers
NCT: NCT07231861 · 25BA11701