NCT02730689

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1 healthy-volunteers

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

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

March 16, 2016

Last Update Submit

April 1, 2016

Conditions

Healthy Volunteers

Keywords

DP-R207RosuvastatinEzetimibe

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration versus time curve (AUC)

    0-72hr

  • Peak Plasma Concentration (Cmax)

    0-72hr

Study Arms (2)

A group

EXPERIMENTAL

DP-R207 \>\> rosuvastatin+ezetimibe

Drug: DP-R207Drug: RosuvastatinDrug: Ezetimibe

B group

ACTIVE COMPARATOR

rosuvastatin+ezetimibe \>\> DP-R207

Drug: DP-R207Drug: RosuvastatinDrug: Ezetimibe

Interventions

DP-R207DRUG
A groupB group
RosuvastatinDRUG
A groupB group
EzetimibeDRUG
A groupB group

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • subjects have an allergy reaction of this drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Rosuvastatin CalciumEzetimibe

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAzetidinesAzetines

Study Design

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

Study Record Dates

First Submitted

March 16, 2016

First Posted

April 6, 2016

Study Start

December 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 6, 2016

Record last verified: 2015-05