Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02127320
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosuvastatin 20mg Drug: Ezetimibe 10mg Drug: Rosuvastatin 20mg + Ezetimibe 10mg Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe in Healthy Male Subjects
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1
Rosuvastatin 20mg → Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg
Drug: Rosuvastatin 20mg
Drug: Ezetimibe 10mg
Drug: Rosuvastatin 20mg + Ezetimibe 10mg
Experimental: Sequence 2
Rosuvastatin 20mg and Ezetimibe 10mg→ Rosuvastatin 20mg → Ezetimibe 10mg
Drug: Rosuvastatin 20mg
Drug: Ezetimibe 10mg
Drug: Rosuvastatin 20mg + Ezetimibe 10mg
Experimental: Sequence 3
Ezetimibe 10mg → Rosuvastatin 20mg and Ezetimibe 10mg → Rosuvastatin 20mg
Drug: Rosuvastatin 20mg
Drug: Ezetimibe 10mg
Drug: Rosuvastatin 20mg + Ezetimibe 10mg
Experimental: Sequence 4
Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg → Rosuvastatin 20mg
Drug: Rosuvastatin 20mg
Drug: Ezetimibe 10mg
Drug: Rosuvastatin 20mg + Ezetimibe 10mg
Experimental: Sequence 5
Ezetimibe 10mg → Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg
Drug: Rosuvastatin 20mg
Drug: Ezetimibe 10mg
Drug: Rosuvastatin 20mg + Ezetimibe 10mg
Experimental: Sequence 6
Rosuvastatin 20mg → Rosuvastatin 20mg and Ezetimibe 10mg → Ezetimibe 10mg
Drug: Rosuvastatin 20mg
Drug: Ezetimibe 10mg
Drug: Rosuvastatin 20mg + Ezetimibe 10mg



Primary Outcome Measures :
  1. Rosuvastatin AUCτ,ss [ Time Frame: 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 ]
  2. Rosuvastatin Cmax,ss [ Time Frame: 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 ]
  3. Ezetimibe Cmax,ss [ Time Frame: 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 ]
  4. Ezetimibe AUCτ,ss [ Time Frame: 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 Outcome Measures :
  1. Rosuvastatin Tmax,ss [ Time Frame: 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 ]
  2. Rosuvastatin t1/2β [ Time Frame: 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 ]
  3. Ezetimibe Tmax,ss [ Time Frame: 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 ]
  4. Ezetimibe t1/2β [ Time Frame: 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127320


Locations
Layout table for location information
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Layout table for investigator information
Principal Investigator: Hyeong-Seok Lim, MD PhD Asan Medical Center

Layout table for additonal information
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02127320    
Other Study ID Numbers: HM-ROZE-101
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors