Hyperlipidemia
Conditions
Keywords
Hyperlipidemia, statin, Ezetimibe, Zetia, Atorvastatin, Lipitor
Brief 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.
Interventions
DRUGEzetimibe
Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
DRUGEzetimibe/atorvastatin 10mg/10mg FDC
Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
DRUGAtorvastatin 80mg
Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
DRUGEzetimibe/atorvastatin 10mg/80mg FDC
Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ) | Hour 0 to Hour 96 |
| Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ) | Hour 0 to Hour 96 |
| Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin | Hour 0 to Hour 48 |
| Maximum plasma concentration (Cmax) of atorvastatin | Hour 0 to Hour 48 |
Outcome results
None listed