Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers (NCT07231861) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
South Korea60 participantsStarted 2025-12
Plain-language summary
To Evaluate the Safety and Pharmacokinetics of Pranlukast hydrate in Healthy Adults.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Cmax of Pranlukast
Timeframe: 0 hour ~ 24 hour after drug administration
2
AUCt of Pranlukast
Timeframe: 0 hour ~ 24 hour after drug administration