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To Evaluate the Pharmacokinetics and Safety of AD-208

NCT ID: NCT04214808

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-03

Study Completion Date

2020-05-04

Brief Summary

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To evaluate pharmacokinetics and safety of AD-208.

Detailed Description

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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.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avodart Soft Capsule 0.5mg to AD-208

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

Group Type EXPERIMENTAL

AD-208

Intervention Type DRUG

Dutasteride 0.2mg

Avodart Soft Capsule 0.5mg

Intervention Type DRUG

Dutasteride 0.5mg

AD-208 to Avodart Soft Capsule 0.5mg

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

Group Type EXPERIMENTAL

AD-208

Intervention Type DRUG

Dutasteride 0.2mg

Avodart Soft Capsule 0.5mg

Intervention Type DRUG

Dutasteride 0.5mg

Interventions

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AD-208

Dutasteride 0.2mg

Intervention Type DRUG

Avodart Soft Capsule 0.5mg

Dutasteride 0.5mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young-Ran Yoon, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-208PK

Identifier Type: -

Identifier Source: org_study_id