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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: DP-R207; Drug: Rosuvastatin; Drug: Ezetimibe

• Registration Number: NCT02730689
• Lead Sponsor: Alvogen Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-05
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-04-01
• Last Update Submitted: 2016-04-01
• Study First Posted: 2016-04-06
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Healthy male subjects age between 19 and 55 signed informed consent

Exclusion Criteria

• subjects have an allergy reaction of this drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B group	DP-R207	rosuvastatin+ezetimibe \>\> DP-R207
A group	DP-R207	DP-R207 \>\> rosuvastatin+ezetimibe
A group	Rosuvastatin	DP-R207 \>\> rosuvastatin+ezetimibe
A group	Ezetimibe	DP-R207 \>\> rosuvastatin+ezetimibe
B group	Rosuvastatin	rosuvastatin+ezetimibe \>\> DP-R207
B group	Ezetimibe	rosuvastatin+ezetimibe \>\> DP-R207

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	0-72hr
Peak Plasma Concentration (Cmax)	0-72hr