To Evaluate the Pharmacokinetics and Safety of AD-208

Phase 1

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: AD-208; Drug: Avodart Soft Capsule 0.5mg

• Registration Number: NCT04214808
• Lead Sponsor: Addpharma Inc.

Brief Summary

To evaluate pharmacokinetics and safety of AD-208.

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 Timeline

• Study First Submitted: 2019-12-26
• Study First Submitted QC: 2019-12-29
• Study First Posted: 2020-01-02
• Study Start: 2020-01-03
• Primary Completion: 2020-02-04
• Study Completion: 2020-05-04
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Avodart Soft Capsule 0.5mg to AD-208	AD-208	Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab
AD-208 to Avodart Soft Capsule 0.5mg	AD-208	Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule
AD-208 to Avodart Soft Capsule 0.5mg	Avodart Soft Capsule 0.5mg	Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule
Avodart Soft Capsule 0.5mg to AD-208	Avodart Soft Capsule 0.5mg	Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of