Back to resultsStudy to Evaluate the Safety and PK of UI018
Primary Purpose
Hyperlipemia, Mixed
Status
Active
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
administration of UI018
co-administration of UIC201806 and UIC201602
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipemia, Mixed
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects between the ages of 19 and 45 years at screening
- Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) [ IBW (kg) = (height(cm) - 100) x 0.9 ]
- Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
UI018
UIC201806 and UIC201602
Arm Description
Outcomes
Primary Outcome Measures
maximum concentration(Cmax)
area under the curve(AUC)
Secondary Outcome Measures
Full Information
NCT ID
NCT05085184
First Posted
September 27, 2021
Last Updated
December 20, 2021
Sponsor
Korea United Pharm. Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05085184
Brief Title
Study to Evaluate the Safety and PK of UI018
Official Title
A Randomized, Open, Single-dose, 2x2x4 Replicate Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of UIC201806 and UIC201602 or Administration of UI018 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
September 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea United Pharm. Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipemia, Mixed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UI018
Arm Type
Experimental
Arm Title
UIC201806 and UIC201602
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
administration of UI018
Intervention Description
Test
Intervention Type
Drug
Intervention Name(s)
co-administration of UIC201806 and UIC201602
Intervention Description
Reference
Primary Outcome Measure Information:
Title
maximum concentration(Cmax)
Time Frame
0 to 96 hrs
Title
area under the curve(AUC)
Time Frame
0 to 96 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects between the ages of 19 and 45 years at screening
Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) [ IBW (kg) = (height(cm) - 100) x 0.9 ]
Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Injin Jang, Dr.
Organizational Affiliation
Seoul National University College of Medicine and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study to Evaluate the Safety and PK of UI018
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