To Evaluate the Pharmacokinetics and Safety of AD-208

Addpharma

Status and phase: Completed; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Drug: Avodart Soft Capsule 0.5mg; Drug: AD-208

Study type: Interventional

Funder types: Industry

Identifiers

NCT04214808

AD-208PK

Details and patient eligibility

About

To evaluate pharmacokinetics and safety of AD-208.

Full description

The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.

Enrollment: 24 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male Adult aged between 19 to 50 at the time of screening visit
• Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
• No evidence of medical symptoms or signs of congenital or no chronic disease

Exclusion criteria

• If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Avodart Soft Capsule 0.5mg to AD-208

Experimental group

Description:

Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab

Treatment:

Drug: AD-208

Drug: Avodart Soft Capsule 0.5mg

AD-208 to Avodart Soft Capsule 0.5mg

Experimental group

Description:

Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule

Treatment:

Drug: AD-208

Drug: Avodart Soft Capsule 0.5mg