Study to Evaluate the Safety and PK of UI018

Korea United Pharm

Status and phase: Unknown; Phase 1

Conditions: Hyperlipemia, Mixed

Treatments: Drug: co-administration of UIC201806 and UIC201602; Drug: administration of UI018

Study type: Interventional

Funder types: Industry

Identifiers

NCT05085184

KUP-UI018-103

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

UI018

Experimental group

Treatment:

Drug: administration of UI018

UIC201806 and UIC201602

Active Comparator group

Treatment:

Drug: co-administration of UIC201806 and UIC201602