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Not yet recruitingNCT07722871Updated Jul 27, 2026

A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions in Healthy Adult Male Volunteers

A Phase 1 interventional study of AD-116A and AD-1161 in Benign Prostatic Hyperplasia, sponsored by Addpharma Inc.. Not yet recruiting at 1 site in South Korea. Open to male participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Addpharma Inc. (part of Yuhan Corporation) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
19 Years and older
Sex
Male
01

Study summary

This study compares and evaluates the bioequivalence of AD-116A and AD-1161 in healthy adult male volunteers under fed conditions.

02

Conditions studied

  • Benign Prostatic Hyperplasia

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03

In context

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

This study's planned enrollment of 44 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Addpharma Inc. is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

First submitted after Addpharma Inc. became part of Yuhan Corporation.

Browse Addpharma Inc. studies →All Yuhan Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Body weight equal to or greater than 50 kg and (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

Exclusion Criteria:

  • Participation in another clinical study with an drug within 6 months prior to the scheduled first administration
  • Other exclusions applied
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Sequence A(RT)

    Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116A)

    Drug: AD-116A · Drug: AD-1161

  • Experimental
    Sequence B(TR)

    Period 1 : Test Drug(AD-116A), Period 2 : Reference Drug(AD-1161)

    Drug: AD-116A · Drug: AD-1161

Interventions

  • DrugAD-116A

    Oral Capsule

  • DrugAD-1161

    Oral Capsule

06

What researchers measure

Primary outcomes

  1. 1. Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of AD-116A

    Time frame: [Time Frame: pre-dose (0hour) to 48hours]

Secondary outcomes

  1. 2. Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-116A

    Time frame: [Time Frame: pre-dose (0hour) to 48hours]

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Oct 2026, 3 months later.

Of 26 industry-sponsored phase 1 interventional studies under Prostatic Hyperplasia, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 4. This study's planned 3 months is close to that.

Counting every sponsor, half of 34 studies reached it within 3 months; a quarter within 1 and three quarters within 6.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2026
First posted
Jul 23, 2026
StartEst.
Jul 2026
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2026
Last update
Jul 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07722871
Lead sponsor
Addpharma Inc.
Responsible party
Sponsor
First posted
Jul 23, 2026
Start date
Jul 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jul 27, 2026

Study contacts

TaeBin Jeong
Contact
tbjeong@addpharma.co.kr
+82-31-605-7641

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: AD-1161

Other studies in this condition

Prostatic Hyperplasia →

Other studies from this sponsor

Addpharma Inc. →

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