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

Korábbi kezelés

• 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.
• Known hypersensitivity to the investigational product or its components.

Más betegség

• History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
• History of clinically significant psychiatric illness.

Laborértékek

• Known metabolic or genetic disorders such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or phenylketonuria.

Egyéb

• Pregnant or breastfeeding women, or women with a possibility of pregnancy.

• 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.