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Study 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
Korea United Pharm. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipemia, Mixed

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 27, 2021
Last Updated
December 20, 2021
Sponsor
Korea United Pharm. Inc.
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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

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Study to Evaluate the Safety and PK of UI018

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