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OpenTrials
Completed

NCT Number: NCT04214808

To Evaluate the Pharmacokinetics and Safety of AD-208

To evaluate pharmacokinetics and safety of AD-208.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, 41944, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD-208

Drug

Dutasteride 0.2mg

Avodart Soft Capsule 0.5mg

Drug

Dutasteride 0.5mg

Primary outcomes

  1. Area under the curve in time plot (AUCt)

    Time frame: Pre-dose(0 hour) to 72 hour

    AUCt of the total ingredient of dutasteride

  2. Peak Plasma Concentration (Cmax)

    Time frame: Pre-dose(0 hour) to 72 hour

    Cmax of the total ingredient of dutasteride

Secondary outcomes

  1. Area under the curve in time plot (AUCinf)

    Time frame: Pre-dose(0 hour) to 72 hour

    AUCinf of the total ingredient of dutasteride

  2. Time to reach Cmax(Tmax)

    Time frame: Pre-dose(0 hour) to 72 hour

    Tmax of the total ingredient of dutasteride

  3. Effective half-life(t1/2)

    Time frame: Pre-dose(0 hour) to 72 hour

    t1/2 of the total ingredient of dutasteride

  4. Clearance(CL/F)

    Time frame: Pre-dose(0 hour) to 72 hour

    CL/F of the total ingredient of dutasteride

  5. Volume of distribution(Vd/F)

    Time frame: Pre-dose(0 hour) to 72 hour

    Vd/F of the total ingredient of dutasteride

Other outcomes

  1. Number of participants with adverse events

    Time frame: From Day -1 until Day 59

    Incidence rate of adverse events

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 2, 2020
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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