to Investigate the Pharmacokinetic Interactions and Safety Between Rosuvastatin and Ezetimibe in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ezetrol; Drug: Crestor+Ezetrol; Drug: Crestor

• Registration Number: NCT02289430
• Lead Sponsor: NVP Healthcare

Brief Summary

The purpose of this study is to compare the drug interaction of pharmacokinetics of rosuvastatin and ezetimibe.

Detailed Description

drug interaction : rosuvastatin, ezetimibe

Study Timeline

• Study First Submitted: 2014-11-09
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-13
• Study Start: 2014-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 59

Inclusion Criteria

• Healthy male subjects age between 19 and 45 singed informed consent

Exclusion Criteria

• Hypotension or hypertension has a history of allergy reaction of this drug or other drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ezetrol	Ezetrol	ezetimibe
Crestor+Ezetrol	Crestor+Ezetrol	rosuvastatin+ezetimibe
Crestor	Crestor	rosuvastatin

Primary Outcome Measures

Name	Time	Method
Area Under Curve	0-24h