NCT02127320

Brief Summary

The purpose of this study is to investigate the pharmacokinetic drug interactions between Rosuvastatin and Ezetimibe in Healthy Male Subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2014

Typical duration for phase_1 healthy

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

April 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

October 12, 2016

Status Verified

July 1, 2014

Enrollment Period

3 months

First QC Date

April 29, 2014

Last Update Submit

October 11, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Rosuvastatin AUCτ,ss

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

  • Rosuvastatin Cmax,ss

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

  • Ezetimibe Cmax,ss

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

  • Ezetimibe AUCτ,ss

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

Secondary Outcomes (4)

  • Rosuvastatin Tmax,ss

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

  • Rosuvastatin t1/2β

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

  • Ezetimibe Tmax,ss

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

  • Ezetimibe t1/2β

    1D 0h(predose), 9D 0h, 10D 0h, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 11D 0h, 12D 0h, 13D 0h

Study Arms (6)

Sequence 1

EXPERIMENTAL

Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg

Drug: Rosuvastatin 20mgDrug: Ezetimibe 10mgDrug: Rosuvastatin 20mg + Ezetimibe 10mg

Sequence 2

EXPERIMENTAL

Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg

Drug: Rosuvastatin 20mgDrug: Ezetimibe 10mgDrug: Rosuvastatin 20mg + Ezetimibe 10mg

Sequence 3

EXPERIMENTAL

Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg

Drug: Rosuvastatin 20mgDrug: Ezetimibe 10mgDrug: Rosuvastatin 20mg + Ezetimibe 10mg

Sequence 4

EXPERIMENTAL

Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg

Drug: Rosuvastatin 20mgDrug: Ezetimibe 10mgDrug: Rosuvastatin 20mg + Ezetimibe 10mg

Sequence 5

EXPERIMENTAL

Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg

Drug: Rosuvastatin 20mgDrug: Ezetimibe 10mgDrug: Rosuvastatin 20mg + Ezetimibe 10mg

Sequence 6

EXPERIMENTAL

Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg

Drug: Rosuvastatin 20mgDrug: Ezetimibe 10mgDrug: Rosuvastatin 20mg + Ezetimibe 10mg

Interventions

Rosuvastatin 20mgDRUG
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Ezetimibe 10mgDRUG
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Rosuvastatin 20mg + Ezetimibe 10mgDRUG
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteer, age 19\~45 years
  • The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

You may not qualify if:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
  • History of relevant drug allergies or clinically significant hypersensitivity reaction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Korea, Republic of, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin CalciumEzetimibe

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Hyeong-Seok Lim, MD PhD

    Asan 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

April 29, 2014

First Posted

April 30, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

October 12, 2016

Record last verified: 2014-07

Locations

KR(1)