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A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236430
First Posted: November 8, 2010
Last Update Posted: December 31, 2014
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The intent of this study is to demonstrate that single doses of the Final Market Image (FMI) ezetimibe/atorvastatin 10mg/10mg and 10mg/80mg fixed dose combination (FDC) tablets are bioequivalent to the same doses of ezetimibe (ZETIA®) and atorvastatin (LIPITOR®) that are coadministered as individual tablets in healthy adults.

Condition Intervention Phase
Hyperlipidemia Drug: Ezetimibe Drug: Ezetimibe/atorvastatin 10mg/10mg FDC Drug: Atorvastatin 10mg Drug: Atorvastatin 80mg Drug: Ezetimibe/atorvastatin 10mg/80mg FDC Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin [ Time Frame: Hour 0 to Hour 48 ]
  • Maximum plasma concentration (Cmax) of atorvastatin [ Time Frame: Hour 0 to Hour 48 ]
  • Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ) [ Time Frame: Hour 0 to Hour 96 ]
  • Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ) [ Time Frame: Hour 0 to Hour 96 ]

Enrollment: 200
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ezetimibe 10mg and Atorvastatin 10mg
Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered
Drug: Ezetimibe
Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
Other Name: Zetia
Drug: Atorvastatin 10mg
Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
Other Name: Lipitor
Experimental: 10mg Ezetimibe/10mg Atorvastatin
10mg Ezetimibe/10mg atorvastatin combination tablet
Drug: Ezetimibe/atorvastatin 10mg/10mg FDC
Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
Other Name: SCH 900068
Active Comparator: Ezetimibe 10mg and Atorvastatin 80mg
Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered
Drug: Ezetimibe
Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
Other Name: Zetia
Drug: Atorvastatin 80mg
Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
Other Name: Lipitor
Experimental: 10mg Ezetimibe/80mg Atorvastatin
Ezetimibe/atorvastatin 10mg/80mg combination tablet
Drug: Ezetimibe/atorvastatin 10mg/80mg FDC
Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).
Other Name: SCH 900068

  Eligibility

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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy adult males and females age 18-55 years
  • Body mass index (BMI) between 18-35 kg/m^2
  • Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis), electrocardiogram, and vital signs must be within normal limits
  • Must agree to refrain from consumption of red wine, grapefruit, and grapefruit-containing products, orange and apple juices, and orange- and apple-containing products from beginning approximately 2 weeks prior to administration of the initial dose of study drug, throughout the study (including the washout interval between treatment periods), and until the poststudy visit

Exclusion Criteria

  • Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
  • History of any infectious disease within 4 weeks prior to drug administration
  • Have demonstrated allergic reactions or hypersensitivities or intolerance to atorvastatin or other 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, ezetimibe, or any component/excipient of the study drug or other food, drug, atopic reactions or asthmatic episodes which, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial.
  • Have a history of prior myopathy or abnormality in liver function studies with statin therapy.
  • Are positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV.
  • Have donated blood in the past 60 days
  • Consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day.
  Contacts and Locations
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): NCT01236430


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Michael Seiberling, MD Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01236430     History of Changes
Other Study ID Numbers: P07551
First Submitted: November 5, 2010
First Posted: November 8, 2010
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Merck Sharp & Dohme Corp.:
Hyperlipidemia
statin
Ezetimibe
Zetia
Atorvastatin
Lipitor

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors