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 2026-07-20.
Sponsored by Addpharma Inc. (part of Yuhan Corporation) · Phase 1, Interventional, and Treatment
The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers
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 →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.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116A)
Drug: AD-116A · Drug: AD-1161
Period 1 : Test Drug(AD-116A), Period 2 : Reference Drug(AD-1161)
Drug: AD-116A · Drug: AD-1161
Oral Capsule
Oral Capsule
Area under the plasma concentration-time curve during dosing interval (AUCt)
AUCt of AD-116A
Time frame: pre-dose (0hour) to 72hours
Maximum concentration of drug in plasma (Cmax)
Cmax of AD-116A
Time frame: pre-dose (0hour) to 72hours
Start is estimated for Jul 2026; primary completion for Aug 2026, 1 month 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 1 month is below 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.
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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Studies of the drug tested here: AD-1161