Moderate-to-severe Benign Prostatic Hyperplasia (BPH)Phase 1NCT07643233
Bioequivalence Study of AJU-G721 and G721R in Healthy Adult Volunteers Under Fed Conditions
A Phase 1 study testing Test Drug and Reference Drug in people with Moderate-to-severe Benign Prostatic Hyperplasia (BPH), run by AJU Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 19 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Moderate-to-severe Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Test Drug and Reference Drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2026to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Randomized, Fed, 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.
- Being tested
- Test Drug, Reference Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test DrugDrug
AJU-G721
Reference DrugDrug
G721R
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose Receives: Drug: Test Drug; Drug: Reference Drug |
| Sequence B | Experimental | Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose Receives: Drug: Test Drug; Drug: Reference Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Tamsulosin.
To assess the maximum observed plasma concentration (Cmax) of Tamsulosin.
Measured: 0 hour ~ 48 hour after drug administration
AUCt of Tamsulosin
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Tamsulosin
Measured: 0 hour ~ 48 hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AJU Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643233
- Sponsor's protocol ID
- 25BPH11802
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Fed, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-G721" and "G721R" in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT07643233
- Acronym / sponsor ID
- 25BPH11802
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AJU Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Test Drug, Drug: Reference DrugPeriod 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose |
| Sequence B | Experimental | Drug: Test Drug, Drug: Reference DrugPeriod 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test DrugAJU-G721 | Drug | Sequence A, Sequence B |
| Reference DrugG721R | Drug | Sequence A, Sequence B |
Primary outcome
Cmax of Tamsulosin.
Time frame: 0 hour ~ 48 hour after drug administration
To assess the maximum observed plasma concentration (Cmax) of Tamsulosin.
AUCt of Tamsulosin
Time frame: 0 hour ~ 48 hour after drug administration
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Tamsulosin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test Drug and Reference Drug in people with Moderate-to-severe Benign Prostatic Hyperplasia (BPH), run by AJU Pharm Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Tamsulosin. (time frame: 0 hour ~ 48 hour after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.