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

NCT01236430 | Completed Phase 1

• 1 other identifier: P07551
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hyperlipidemia; statin; Ezetimibe; Zetia; Atorvastatin; Lipitor

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Ezetimibe 10mg and Atorvastatin 10mg

ACTIVE COMPARATOR

Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered

Drug: Ezetimibe; Drug: Atorvastatin 10mg

10mg Ezetimibe/10mg Atorvastatin

EXPERIMENTAL

10mg Ezetimibe/10mg atorvastatin combination tablet

Drug: Ezetimibe/atorvastatin 10mg/10mg FDC

Ezetimibe 10mg and Atorvastatin 80mg

ACTIVE COMPARATOR

Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered

Drug: Ezetimibe; Drug: Atorvastatin 80mg

10mg Ezetimibe/80mg Atorvastatin

EXPERIMENTAL

Ezetimibe/atorvastatin 10mg/80mg combination tablet

Drug: Ezetimibe/atorvastatin 10mg/80mg FDC

Interventions

Ezetimibe DRUG

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

Also known as: Zetia

Ezetimibe 10mg and Atorvastatin 10mg; Ezetimibe 10mg and Atorvastatin 80mg

Ezetimibe/atorvastatin 10mg/10mg FDC DRUG

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

Also known as: SCH 900068

10mg Ezetimibe/10mg Atorvastatin

Atorvastatin 10mg DRUG

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

Also known as: Lipitor

Ezetimibe 10mg and Atorvastatin 10mg

Atorvastatin 80mg DRUG

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

Also known as: Lipitor

Ezetimibe 10mg and Atorvastatin 80mg

Ezetimibe/atorvastatin 10mg/80mg FDC DRUG

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

Also known as: SCH 900068

10mg Ezetimibe/80mg Atorvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Michael Seiberling, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 16, 2022

Record last verified: 2022-02