Study to Evaluate the Safety and PK of UI018

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05085184

Enrollment

Registered

2021-10-20

Start date

2021-09-06

Completion date

2022-09-05

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipemia, Mixed

Brief summary

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

Interventions

DRUGadministration of UI018

Test

DRUGco-administration of UIC201806 and UIC201602

Reference

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
maximum concentration(Cmax)	0 to 96 hrs
area under the curve(AUC)	0 to 96 hrs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026