Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers

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.

• AJU-R713 (Drug): Oral formulation
• R713R (Drug): Oral formulation

Primary outcomes

• Cmax of Pranlukast [0 hour ~ 24 hour after drug administration]: To assess the maximum observed plasma concentration (Cmax) of Pranlukast
• AUCt of Pranlukast [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

Sex: All, ages: 19 Years to any, accepts healthy volunteers

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.