To Evaluate the Pharmacokinetics and Safety of AD-208

A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208

To evaluate pharmacokinetics and safety of AD-208.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: AD-208; Drug: Avodart Soft Capsule 0.5mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avodart Soft Capsule 0.5mg to AD-208; Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab	Drug: AD-208; Dutasteride 0.2mg; Drug: Avodart Soft Capsule 0.5mg; Dutasteride 0.5mg
Experimental: AD-208 to Avodart Soft Capsule 0.5mg; Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule	Drug: AD-208; Dutasteride 0.2mg; Drug: Avodart Soft Capsule 0.5mg; Dutasteride 0.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve in time plot (AUCt)	AUCt of the total ingredient of dutasteride	Pre-dose(0 hour) to 72 hour
Peak Plasma Concentration (Cmax)	Cmax of the total ingredient of dutasteride	Pre-dose(0 hour) to 72 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve in time plot (AUCinf)	AUCinf of the total ingredient of dutasteride	Pre-dose(0 hour) to 72 hour
Time to reach Cmax(Tmax)	Tmax of the total ingredient of dutasteride	Pre-dose(0 hour) to 72 hour
Effective half-life(t1/2)	t1/2 of the total ingredient of dutasteride	Pre-dose(0 hour) to 72 hour
Clearance(CL/F)	CL/F of the total ingredient of dutasteride	Pre-dose(0 hour) to 72 hour
Volume of distribution(Vd/F)	Vd/F of the total ingredient of dutasteride	Pre-dose(0 hour) to 72 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Incidence rate of adverse events	From Day -1 until Day 59

Collaborators and Investigators

• Sponsor: Addpharma Inc.
• Investigators: Principal Investigator: Young-Ran Yoon, M.D., Ph.D, Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): May 4, 2020

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: December 29, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: AD-208PK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No