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Status unknownNCT05085184Updated Dec 21, 2021

Study to Evaluate the Safety and PK of UI018

A Phase 1 interventional study of administration of UI018 and co-administration of UIC201806 and UIC201602 in Hyperlipemia, Mixed, sponsored by Korea United Pharm. Inc.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-21.

Sponsored by Korea United Pharm. Inc. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study summary

This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.

02

Conditions studied

  • Hyperlipemia, Mixed

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03

In context

Hyperlipidemias

820 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 44 is below the median of 88 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Korea United Pharm. Inc. is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    UI018

    Drug: administration of UI018

  • Active comparator
    UIC201806 and UIC201602

    Drug: co-administration of UIC201806 and UIC201602

Interventions

  • Drugadministration of UI018

    Test

  • Drugco-administration of UIC201806 and UIC201602

    Reference

06

What researchers measure

Primary outcomes

  1. maximum concentration(Cmax)

    Time frame: 0 to 96 hrs

  2. area under the curve(AUC)

    Time frame: 0 to 96 hrs

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Jongno-gu 110-744, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05085184
Lead sponsor
Korea United Pharm. Inc.
Responsible party
Sponsor
First posted
Oct 20, 2021
Start date
Sep 6, 2021
Primary completion
Nov 30, 2021
Completion
Sep 5, 2022 (estimated)
Last update
Dec 21, 2021

Study contacts

Injin Jang, Dr.
principal investigator · Seoul National University College of Medicine and Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Korea United Pharm. Inc.

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