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Study to Evaluate the Safety and PK of UI018

NCT ID: NCT05085184

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-06

Study Completion Date

2022-09-05

Brief Summary

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

Detailed Description

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Conditions

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Hyperlipemia, Mixed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UI018

Group Type EXPERIMENTAL

administration of UI018

Intervention Type DRUG

Test

UIC201806 and UIC201602

Group Type ACTIVE_COMPARATOR

co-administration of UIC201806 and UIC201602

Intervention Type DRUG

Reference

Interventions

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administration of UI018

Test

Intervention Type DRUG

co-administration of UIC201806 and UIC201602

Reference

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korea United Pharm. Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Injin Jang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine and Hospital

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KUP-UI018-103

Identifier Type: -

Identifier Source: org_study_id