NCT02289430

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

2 months

First QC Date

November 9, 2014

Last Update Submit

March 24, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Area Under Curve

    0-24h

Study Arms (3)

Crestor+Ezetrol

EXPERIMENTAL

rosuvastatin+ezetimibe

Drug: Crestor+Ezetrol

Ezetrol

ACTIVE COMPARATOR

ezetimibe

Drug: Ezetrol

Crestor

ACTIVE COMPARATOR

rosuvastatin

Drug: Crestor

Interventions

Crestor+EzetrolDRUG

rosuvastatin+ezetimibe

Also known as: rosuvatatin+ezetimibe
Crestor+Ezetrol
EzetrolDRUG

ezetimibe

Also known as: ezetimibe
Ezetrol
CrestorDRUG

rosuvastatin

Also known as: rosuvastatin
Crestor

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

EzetimibeRosuvastatin Calcium

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • Shin D Seong, M.D.

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2014

First Posted

November 13, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share