Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fasting Conditions (NCT07643220) | Clinical Trial Compass
RecruitingPhase 1
Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fasting Conditions
South Korea44 participantsStarted 2026-06
Plain-language summary
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
Who can participate
Age range
19 Years – 54 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax of Dutasteride and Tamsulosin.
Timeframe: [Time Frame: 0 hour ~ 72 hour after drug administration]
2
AUCt of Dutasteride and Tamsulosin
Timeframe: [Time Frame: 0 hour ~ 72 hour after drug administration]