Clinical trial NCT01236430: A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
Official title: A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia
statin
Ezetimibe
Zetia
Atorvastatin
Lipitor
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin
timeFrame: Hour 0 to Hour 48
measure: Maximum plasma concentration (Cmax) of atorvastatin
timeFrame: Hour 0 to Hour 48
measure: Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ)
timeFrame: Hour 0 to Hour 96
measure: Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)
timeFrame: Hour 0 to Hour 96
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland
name: Michael Seiberling, MD
role: PRINCIPAL_INVESTIGATOR
References: