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

Organon

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemia

Treatments: Drug: Ezetimibe/atorvastatin 10mg/10mg FDC; Drug: Atorvastatin 80mg; Drug: Ezetimibe/atorvastatin 10mg/80mg FDC; Drug: Atorvastatin 10mg; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01236430

P07551

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Ezetimibe 10mg and Atorvastatin 10mg

Active Comparator group

Description:

Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered

Treatment:

Drug: Ezetimibe

Drug: Atorvastatin 10mg

10mg Ezetimibe/10mg Atorvastatin

Experimental group

Description:

10mg Ezetimibe/10mg atorvastatin combination tablet

Treatment:

Drug: Ezetimibe/atorvastatin 10mg/10mg FDC

Ezetimibe 10mg and Atorvastatin 80mg

Active Comparator group

Description:

Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered

Treatment:

Drug: Ezetimibe

Drug: Atorvastatin 80mg

10mg Ezetimibe/80mg Atorvastatin

Experimental group

Description:

Ezetimibe/atorvastatin 10mg/80mg combination tablet

Treatment:

Drug: Ezetimibe/atorvastatin 10mg/80mg FDC