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Can a new pill for enlarged prostate match the original?

NCT ID NCT07722871

Disease control Sponsor: Addpharma Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This trial is testing whether a new formulation of a drug for benign prostatic hyperplasia (enlarged prostate) works the same as the existing version. Healthy adult male volunteers receive a single dose of each formulation after a meal, and researchers compare how much drug gets into the bloodstream. The goal is to see if the new version can be used as an equivalent alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a new formulation of a drug for benign prostatic hyperplasia (AD-116A) compared to the original (AD-1161)
What this could lead to
If the new formulation is shown to be equivalent, it could offer an alternative treatment option for enlarged prostate.
What could go wrong
This is an early-phase study in healthy volunteers, not patients, so results may not predict real-world effectiveness or safety.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

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

19 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Body weight equal to or greater than 50 kg and body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * Age equal to or greater than 19 years in healthy adult male volunteers at the time of screening visit Exclusion Criteria: * Participation in another clinical study with an investigational drug within 6 months prior to the scheduled first administration * Other exclusions applied

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • H PLUS YANGJI HOSPITAL, Seoul

    Seoul, South Korea

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