Back to resultsTo Evaluate the Pharmacokinetics and Safety of AD-208
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-208
Avodart Soft Capsule 0.5mg
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
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
Sites / Locations
- Kyungpook National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Avodart Soft Capsule 0.5mg to AD-208
AD-208 to Avodart Soft Capsule 0.5mg
Arm Description
Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab
Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule
Outcomes
Primary Outcome Measures
Area under the curve in time plot (AUCt)
AUCt of the total ingredient of dutasteride
Peak Plasma Concentration (Cmax)
Cmax of the total ingredient of dutasteride
Secondary Outcome Measures
Area under the curve in time plot (AUCinf)
AUCinf of the total ingredient of dutasteride
Time to reach Cmax(Tmax)
Tmax of the total ingredient of dutasteride
Effective half-life(t1/2)
t1/2 of the total ingredient of dutasteride
Clearance(CL/F)
CL/F of the total ingredient of dutasteride
Volume of distribution(Vd/F)
Vd/F of the total ingredient of dutasteride
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04214808
Brief Title
To Evaluate the Pharmacokinetics and Safety of AD-208
Official Title
A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2020 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avodart Soft Capsule 0.5mg to AD-208
Arm Type
Experimental
Arm Description
Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab
Arm Title
AD-208 to Avodart Soft Capsule 0.5mg
Arm Type
Experimental
Arm Description
Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule
Intervention Type
Drug
Intervention Name(s)
AD-208
Intervention Description
Dutasteride 0.2mg
Intervention Type
Drug
Intervention Name(s)
Avodart Soft Capsule 0.5mg
Intervention Description
Dutasteride 0.5mg
Primary Outcome Measure Information:
Title
Area under the curve in time plot (AUCt)
Description
AUCt of the total ingredient of dutasteride
Time Frame
Pre-dose(0 hour) to 72 hour
Title
Peak Plasma Concentration (Cmax)
Description
Cmax of the total ingredient of dutasteride
Time Frame
Pre-dose(0 hour) to 72 hour
Secondary Outcome Measure Information:
Title
Area under the curve in time plot (AUCinf)
Description
AUCinf of the total ingredient of dutasteride
Time Frame
Pre-dose(0 hour) to 72 hour
Title
Time to reach Cmax(Tmax)
Description
Tmax of the total ingredient of dutasteride
Time Frame
Pre-dose(0 hour) to 72 hour
Title
Effective half-life(t1/2)
Description
t1/2 of the total ingredient of dutasteride
Time Frame
Pre-dose(0 hour) to 72 hour
Title
Clearance(CL/F)
Description
CL/F of the total ingredient of dutasteride
Time Frame
Pre-dose(0 hour) to 72 hour
Title
Volume of distribution(Vd/F)
Description
Vd/F of the total ingredient of dutasteride
Time Frame
Pre-dose(0 hour) to 72 hour
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Description
Incidence rate of adverse events
Time Frame
From Day -1 until Day 59
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Ran Yoon, M.D., Ph.D
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Pharmacokinetics and Safety of AD-208
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