NCT02029625

Brief Summary

The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

January 5, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

28 days

First QC Date

January 5, 2014

Last Update Submit

March 24, 2016

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • AUClast

    0-96hr

Secondary Outcomes (1)

  • AUCinf

    0-96hr

Study Arms (2)

NVP-1205

EXPERIMENTAL

administration of NVP-1205(rosuvastatin+ezetimibe)

Drug: NVP-1205

rosuvastatin and ezetimibe

ACTIVE COMPARATOR

coadministration of rosuvastatin and ezetimibe

Drug: rosuvastatin and ezetimibe

Interventions

NVP-1205DRUG

rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2

Also known as: NVP-1205(rosuvastatin+ezetimibe)
NVP-1205
rosuvastatin and ezetimibeDRUG

coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2

Also known as: Crestor and Ezetrol
rosuvastatin and ezetimibe

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 a history of allergy reaction of this drug or other drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National Hospital

Jung-gu, Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin CalciumEzetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yoon Yo Ran, M.D., Ph,D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 5, 2014

First Posted

January 8, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)