Study to Evaluate the Safety and PK of UI018
Sponsor
Korea United Pharm. Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05085184
Collaborator
(none)
44
1
2
12
3.7
Study Details
Study Description
Brief Summary
This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
44 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Sep 6, 2021
Actual Primary Completion Date
:
Nov 30, 2021
Anticipated Study Completion Date
:
Sep 5, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: UI018
|
Drug: administration of UI018
Test
|
| Active Comparator: UIC201806 and UIC201602
|
Drug: co-administration of UIC201806 and UIC201602
Reference
|
Outcome Measures
Primary Outcome Measures
- maximum concentration(Cmax) [0 to 96 hrs]
- area under the curve(AUC) [0 to 96 hrs]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Jongno-gu | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Korea United Pharm. Inc.
Investigators
- Principal Investigator: Injin Jang, Dr., Seoul National University College of Medicine and Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Korea United Pharm. Inc.
ClinicalTrials.gov Identifier:
NCT05085184
Other Study ID Numbers:
- KUP-UI018-103
First Posted:
Oct 20, 2021
Last Update Posted:
Dec 21, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms: