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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT01236430

Collaborator

(none)

200

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia	Drug: Ezetimibe Drug: Ezetimibe/atorvastatin 10mg/10mg FDC Drug: Atorvastatin 10mg Drug: Atorvastatin 80mg Drug: Ezetimibe/atorvastatin 10mg/80mg FDC	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ezetimibe 10mg and Atorvastatin 10mg Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered	Drug: Ezetimibe Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours). Other Names: Zetia Drug: Atorvastatin 10mg Atorvastatin 10mg given orally after an overnight fast (at least 10 hours). Other Names: Lipitor
Experimental: 10mg Ezetimibe/10mg Atorvastatin 10mg Ezetimibe/10mg atorvastatin combination tablet	Drug: Ezetimibe/atorvastatin 10mg/10mg FDC Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours). Other Names: SCH 900068
Active Comparator: Ezetimibe 10mg and Atorvastatin 80mg Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered	Drug: Ezetimibe Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours). Other Names: Zetia Drug: Atorvastatin 80mg Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours). Other Names: Lipitor
Experimental: 10mg Ezetimibe/80mg Atorvastatin Ezetimibe/atorvastatin 10mg/80mg combination tablet	Drug: Ezetimibe/atorvastatin 10mg/80mg FDC Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours). Other Names: SCH 900068

Outcome Measures

Primary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.