Study to Evaluate the Safety and PK of UI018

Korea United Pharm. Inc.44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipemia, Mixed

Interventions

administration of UI018DRUG

Test

co-administration of UIC201806 and UIC201602DRUG

Reference

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Outcomes

Primary Outcomes

maximum concentration(Cmax)

Time frame: 0 to 96 hrs

area under the curve(AUC)

Time frame: 0 to 96 hrs

Data from ClinicalTrials.gov

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