Back to resultsA Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B
Primary Purpose
Hyperlipidemias
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-221
AD-221A and AD-221B
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- H+ Yangji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Arm Description
Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)
Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax)
Cmax of AD-221
Area Under the Curve in time plot (AUCt)
AUCt of AD-221
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05202405
Brief Title
A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B
Official Title
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221)
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B)
Intervention Type
Drug
Intervention Name(s)
AD-221
Intervention Description
AD-221 Oral Tablet
Intervention Type
Drug
Intervention Name(s)
AD-221A and AD-221B
Intervention Description
AD-221A Oral Tablet + AD-221B Oral Tablet
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Cmax of AD-221
Time Frame
pre-dose to 72 hours
Title
Area Under the Curve in time plot (AUCt)
Description
AUCt of AD-221
Time Frame
pre-dose to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
H+ Yangji Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B
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