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

Addpharma

Status and phase: Enrolling; Phase 1

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: AD-116, AD-1161

Study type: Interventional

Funder types: Industry

Identifiers

NCT07444385

AD-116FED

Details and patient eligibility

About

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

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(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2.

Treatment:

Drug: AD-116, AD-1161

Sequence B

Experimental group

Description:

Period 1 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 2.

Treatment:

Drug: AD-116, AD-1161