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NCT07715305

Overview

NCT ID: NCT07715305
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 Fasting Conditions
Brief Summary: The study compare and evaluate the bioequivalence between the administration of AD-116A and the administration of AD-1161 in healthy adult male volunteers
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 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

Central Contacts: Soyoung HwangContact
syhwang@addpharma.co.kr+82-31-891-6919