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NCT07722871

Overview

NCT ID: NCT07722871
Lead Sponsor: Addpharma Inc.INDUSTRY
Official Title: An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of AD-116A Compared to AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions
Brief Summary: This study compares and evaluates the bioequivalence of AD-116A and AD-1161 in healthy adult male volunteers under fed conditions.
Conditions: Benign Prostatic Hyperplasia
Interventions: AD-116A
AD-1161

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: Yes
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

Central Contacts: TaeBin JeongContact
tbjeong@addpharma.co.kr+82-31-605-7641