A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone

Alvogen Korea66 enrolled

Overview

The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered alone in health male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

DP-R207DRUG

RosuvastatinDRUG

EzetimibeDRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects age between 19 and 55 signed informed consent Exclusion Criteria: * subjects have an allergy reaction of this drug

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC)

Time frame: 0-72hr

Peak Plasma Concentration (Cmax)

Time frame: 0-72hr

Data from ClinicalTrials.gov

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