Status:
COMPLETED
A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B
Lead Sponsor:
Addpharma Inc.
Conditions:
Hyperlipidemias
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.
Detailed Description
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.
Eligibility Criteria
Inclusion
- Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
- The Age equal to or greater than 19 in healthy volunteers at the time of screening visit
Exclusion
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05202405
Start Date
January 5 2022
End Date
March 4 2022
Last Update
July 20 2022
Active Locations (1)
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1
H+ Yangji Hospital
Seoul, South Korea