A Clinical Trial to Evaluate the Safety and the Pharmacokinetics of AD-116 Compared to AD-1161 in Healthy Adult Male Volunteers

Addpharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: AD-116; Drug: AD-1161

Study type: Interventional

Funder types: Industry

Identifiers

NCT07103278

AD-116BE

Details and patient eligibility

About

The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-116 and the administration of AD-1161 in healthy adult male volunteers

Enrollment: 44 estimated patients

Sex: Male

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Sequence A

Experimental group

Description:

Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116)

Treatment:

Drug: AD-1161

Drug: AD-116

Sequence B

Experimental group

Description:

Period 1 : Test Drug(AD-116), Period 2 : Reference Drug(AD-1161)

Treatment:

Drug: AD-1161

Drug: AD-116