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

• 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 ]

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.

• Drug: Ezetimibe
  Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
  Other Name: Zetia
• 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
• Drug: Atorvastatin 10mg
  Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
  Other Name: Lipitor
• Drug: Atorvastatin 80mg
  Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
  Other Name: Lipitor
• 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

• Active Comparator: Ezetimibe 10mg and Atorvastatin 10mg
  Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered
  Interventions:

  • Drug: Ezetimibe
  • Drug: Atorvastatin 10mg
• Experimental: 10mg Ezetimibe/10mg Atorvastatin
  10mg Ezetimibe/10mg atorvastatin combination tablet
  Intervention: Drug: Ezetimibe/atorvastatin 10mg/10mg FDC
• Active Comparator: Ezetimibe 10mg and Atorvastatin 80mg
  Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered
  Interventions:

  • Drug: Ezetimibe
  • Drug: Atorvastatin 80mg
• Experimental: 10mg Ezetimibe/80mg Atorvastatin
  Ezetimibe/atorvastatin 10mg/80mg combination tablet
  Intervention: Drug: Ezetimibe/atorvastatin 10mg/80mg FDC

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.