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

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.

Completed

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male subjects age between 19 and 55 signed informed consent

Exclusion criteria

subjects have an allergy reaction of this drug

Treatment and study plan

DP-R207

Drug

Rosuvastatin

Drug

ezetimibe

Drug

Primary outcomes

Area under the plasma concentration versus time curve (AUC)

Time frame: 0-72hr
Peak Plasma Concentration (Cmax)

Time frame: 0-72hr

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study title

A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone in Healthy Male Volunteers

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 6, 2016
Registry last updated: Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed