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NCT07722871
A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions in Healthy Adult Male Volunteers
Conditions: Benign Prostatic Hyperplasia
Sex: Male
Ages: 19 Years – N/A
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 44
Sponsor: Addpharma Inc.
Location: H PLUS YANGJI HOSPITAL, Seoul Seoul
Summary
This study compares and evaluates the bioequivalence of AD-116A and AD-1161 in healthy adult male volunteers under fed conditions.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07722871). StuddyBuddy aggregates publicly available trial information.