Overview

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

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Atorvastatin
Atorvastatin Calcium
Ezetimibe
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.