Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fasting Conditions

An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-G721" and "G721R" in Healthy Adult Male Subjects

To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.

Inclusion Criteria:

• Healthy male adults aged ≥19 years and <55 years at screening.
• Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m².
• Clinically healthy based on medical history, physical examination, ECG, and laboratory test results, as determined by the investigator.
• Willing and able to provide written informed consent.
• Agrees to use medically acceptable contraception during the required study period.

Exclusion Criteria:

• Use of medications known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or other medications that may interfere with the study within 10 days prior to dosing.
• Participation in another clinical trial involving an investigational product 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 resection that may affect drug absorption.
• Known hypersensitivity to dutasteride, tamsulosin, or any component of the investigational product.
• History of psychiatric illness, or any condition considered unsuitable for study participation by the investigator.