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

NCT ID: NCT01236430

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-02-29

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.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ezetimibe 10mg and Atorvastatin 10mg

Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered

Group Type: ACTIVE_COMPARATOR

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).

Atorvastatin 10mg

Intervention Type: DRUG

Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).

10mg Ezetimibe/10mg Atorvastatin

10mg Ezetimibe/10mg atorvastatin combination tablet

Group Type: EXPERIMENTAL

Ezetimibe/atorvastatin 10mg/10mg FDC

Intervention Type: DRUG

Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).

Ezetimibe 10mg and Atorvastatin 80mg

Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered

Group Type: ACTIVE_COMPARATOR

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).

Atorvastatin 80mg

Intervention Type: DRUG

Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).

10mg Ezetimibe/80mg Atorvastatin

Ezetimibe/atorvastatin 10mg/80mg combination tablet

Group Type: EXPERIMENTAL

Ezetimibe/atorvastatin 10mg/80mg FDC

Intervention Type: DRUG

Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).

Interventions

Ezetimibe

Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).

Intervention Type: DRUG

Ezetimibe/atorvastatin 10mg/10mg FDC

Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).

Intervention Type: DRUG

Atorvastatin 10mg

Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).

Intervention Type: DRUG

Atorvastatin 80mg

Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).

Intervention Type: DRUG

Ezetimibe/atorvastatin 10mg/80mg FDC

Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).

Intervention Type: DRUG

Other Intervention Names

Zetia; SCH 900068; Lipitor; Lipitor; SCH 900068

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland

Other Identifiers

P07551

Identifier Type: -

Identifier Source: org_study_id