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NCT04214808 Clinical Trial

To Evaluate the Pharmacokinetics and Safety of AD-208

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04214808
Other study ID # AD-208PK
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 3, 2020
Est. completion date May 4, 2020

Study information
Verified date December 2020
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate pharmacokinetics and safety of AD-208.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date May 4, 2020
Est. primary completion date February 4, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-208
Dutasteride 0.2mg
• Avodart Soft Capsule 0.5mg
Dutasteride 0.5mg

Locations
Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of participants with adverse events Incidence rate of adverse events From Day -1 until Day 59
Primary Area under the curve in time plot (AUCt) AUCt of the total ingredient of dutasteride Pre-dose(0 hour) to 72 hour
Primary Peak Plasma Concentration (Cmax) Cmax of the total ingredient of dutasteride Pre-dose(0 hour) to 72 hour
Secondary Area under the curve in time plot (AUCinf) AUCinf of the total ingredient of dutasteride Pre-dose(0 hour) to 72 hour
Secondary Time to reach Cmax(Tmax) Tmax of the total ingredient of dutasteride Pre-dose(0 hour) to 72 hour
Secondary Effective half-life(t1/2) t1/2 of the total ingredient of dutasteride Pre-dose(0 hour) to 72 hour
Secondary Clearance(CL/F) CL/F of the total ingredient of dutasteride Pre-dose(0 hour) to 72 hour
Secondary Volume of distribution(Vd/F) Vd/F of the total ingredient of dutasteride Pre-dose(0 hour) to 72 hour
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