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Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia

NCT ID: NCT02824380

Last Updated: 2018-03-30

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-10-31

Brief Summary

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An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.

Detailed Description

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Conditions

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Androgenic 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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Sequence A

Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)

Group Type EXPERIMENTAL

DA-4001 H

Intervention Type DRUG

5% minoxidil / high dose of finasteride

DA-4001 L

Intervention Type DRUG

5% minoxidil / low dose of finasteride

Sequence B

Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)

Group Type EXPERIMENTAL

DA-4001 H

Intervention Type DRUG

5% minoxidil / high dose of finasteride

DA-4001 L

Intervention Type DRUG

5% minoxidil / low dose of finasteride

Interventions

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DA-4001 H

5% minoxidil / high dose of finasteride

Intervention Type DRUG

DA-4001 L

5% minoxidil / low dose of finasteride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male, aged between 19 and 65 years, clinically healthy
* BMI between 18.5kg/m2 and 27kg/m2
* Clinical history of Androgenic Alopecia

Exclusion Criteria

* Subject has any dermatological disorders of the scalp
* Subject has a history of hair transplants, hair weaves
* Subject has hypersensitivity to previously prescribed minoxidil or finasteride
* Subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA4001_AGAP_I

Identifier Type: -

Identifier Source: org_study_id