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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01236430
First received: November 5, 2010
Last updated: October 16, 2012
Last verified: October 2012
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of atorvastatin [ Time Frame: Hour 0 to Hour 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ) [ Time Frame: Hour 0 to Hour 96 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01236430     History of Changes
Other Study ID Numbers: P07551
Study First Received: November 5, 2010
Last Updated: October 16, 2012
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on August 21, 2014