Benign Prostatic HyperplasiaPhase 1NCT07444385
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects
A Phase 1 study testing AD-116, AD-1161 in people with Benign Prostatic Hyperplasia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- AD-116, AD-1161
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2026to 8 May 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy adult male volunteers at the time of screening visit
Who cannot join
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
H PLUS YANGJI HOSPITAL, Seoul
Seoul
About this study
Official title: An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Period Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- AD-116, AD-1161
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-116, AD-1161Drug
Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Period 1 : Reference Drug(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2. Receives: Drug: AD-116, AD-1161 |
| Sequence B | Experimental | Period 1 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 2. Receives: Drug: AD-116, AD-1161 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-116
Measured: pre-dose (0hour) to 72hours
Maximum concentration of drug in plasma (Cmax)
Cmax of AD-116
Measured: pre-dose (0hour) to 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start26 Feb 2026
- Primary completion22 Apr 2026 (estimated)
- Study completion8 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444385
- Sponsor's protocol ID
- AD-116FED
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Period Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT07444385
- Acronym / sponsor ID
- AD-116FED
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 22 Apr 2026 (estimated)
- Study completion
- 8 May 2026 (estimated)
- First posted
- 2 Mar 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.
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions 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: AD-116, AD-1161Period 1 : Reference Drug(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2. |
| Sequence B | Experimental | Drug: AD-116, AD-1161Period 1 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 2. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy adult male volunteers at the time of screening visit
Key exclusion criteria (2 listed)
- Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
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 |
|---|---|---|
| AD-116, AD-1161Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence. | Drug | Sequence A, Sequence B |
Primary outcome
Area under the plasma concentration-time curve during dosing interval (AUCt)
Time frame: pre-dose (0hour) to 72hours
AUCt of AD-116
Maximum concentration of drug in plasma (Cmax)
Time frame: pre-dose (0hour) to 72hours
Cmax of AD-116
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 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 AD-116, AD-1161 in people with Benign Prostatic Hyperplasia, run by Addpharma Inc. 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Mar 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?
Contact JaeHun Jung (+82-31-891-5683, jhjung@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve during dosing interval (AUCt) (time frame: pre-dose (0hour) to 72hours). 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 3 Mar 2026.