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.

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.