RecruitingPhase 1NCT07643220
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
Sponsor
AJU Pharm Co., Ltd.
Enrollment
44 participants
Start Date
Jun 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
Eligibility
Sex: MALEMin Age: 19 YearsMax Age: 54 Years
Inclusion Criteria5
- 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 Criteria6
- 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.
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Interventions
DRUGTest Drug
AJU-G721
DRUGReference Drug
G721R
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07643220