New formulation of prostate drug put to the test in healthy volunteers
NCT ID NCT07643220
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time
Summary
This study compares a new formulation (AJU-G721) of a drug used for benign prostatic hyperplasia (BPH) to the original version (G721R) in healthy adult men. The goal is to see if the two versions are absorbed and processed by the body in the same way. Participants receive a single dose of each version on separate occasions, and their blood is tested to measure drug levels. This is a standard step before the new formulation can be considered for use in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dutasteride and Tamsulosin (combination drug)
- What this could lead to
- If the new formulation is shown to be equivalent, it could offer a more affordable or accessible treatment option for men with enlarged prostate.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients, so results may not directly predict effectiveness or safety in the target population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
45 people
The number who actually took part.
- Started
-
Jun 2026
- Finished
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Jul 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 54 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bumin Hospital
Seoul, South Korea
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