A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia
Intervention: Ezetimibe (Drug); Ezetimibe/atorvastatin 10mg/10mg FDC (Drug); Atorvastatin 10mg (Drug); Atorvastatin 80mg (Drug); Ezetimibe/atorvastatin 10mg/80mg FDC (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Michael Seiberling, MD, Principal Investigator, Affiliation: Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland
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.
Clinical Details
Official title: A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatinMaximum plasma concentration (Cmax) of atorvastatin Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ) Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: February 2011
Last updated: December 30, 2014
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