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A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07444385
Enrollment
44
Registered
2026-03-02
Start date
2026-02-26
Completion date
2026-05-08
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Brief summary

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects

Interventions

DRUGAD-116, AD-1161

Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence.

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * Other exclusions applied

Design outcomes

Primary

MeasureTime frameDescription
Area under the plasma concentration-time curve during dosing interval (AUCt)pre-dose (0hour) to 72hoursAUCt of AD-116
Maximum concentration of drug in plasma (Cmax)pre-dose (0hour) to 72hoursCmax of AD-116

Countries

South Korea

Contacts

CONTACTJaeHun Jung
jhjung@addpharma.co.kr+82-31-891-5683

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026