Study to Evaluate the Safety and PK of UI018

Phase 1

• Conditions: Hyperlipemia, Mixed
• Interventions: Drug: co-administration of UIC201806 and UIC201602; Drug: administration of UI018

• Registration Number: NCT05085184
• Lead Sponsor: Korea United Pharm. Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-06
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Primary Completion: 2021-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21
• Study Completion: 2022-09-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UIC201806 and UIC201602	co-administration of UIC201806 and UIC201602	-
UI018	administration of UI018	-

Primary Outcome Measures

Name	Time	Method
area under the curve(AUC)	0 to 96 hrs
maximum concentration(Cmax)	0 to 96 hrs

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of