To Evaluate the Pharmacokinetics and Safety of AD-208
A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208
1 other identifier
interventional
24
1 country
1
Brief Summary
To evaluate pharmacokinetics and safety of AD-208.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 26, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2020
CompletedDecember 2, 2020
December 1, 2020
1 month
December 26, 2019
December 1, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the curve in time plot (AUCt)
AUCt of the total ingredient of dutasteride
Pre-dose(0 hour) to 72 hour
Peak Plasma Concentration (Cmax)
Cmax of the total ingredient of dutasteride
Pre-dose(0 hour) to 72 hour
Secondary Outcomes (5)
Area under the curve in time plot (AUCinf)
Pre-dose(0 hour) to 72 hour
Time to reach Cmax(Tmax)
Pre-dose(0 hour) to 72 hour
Effective half-life(t1/2)
Pre-dose(0 hour) to 72 hour
Clearance(CL/F)
Pre-dose(0 hour) to 72 hour
Volume of distribution(Vd/F)
Pre-dose(0 hour) to 72 hour
Other Outcomes (1)
Number of participants with adverse events
From Day -1 until Day 59
Study Arms (2)
Avodart Soft Capsule 0.5mg to AD-208
EXPERIMENTALPeriod 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab
AD-208 to Avodart Soft Capsule 0.5mg
EXPERIMENTALPeriod 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule
Interventions
Dutasteride 0.5mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addpharma Inc.lead
Study Sites (1)
Kyungpook National University Hospital
Daegu, 41944, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Ran Yoon, M.D., Ph.D
Kyungpook National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2019
First Posted
January 2, 2020
Study Start
January 3, 2020
Primary Completion
February 4, 2020
Study Completion
May 4, 2020
Last Updated
December 2, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share