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Completed

NCT Number: NCT01236430

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ezetimibe

Drug

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

Other names: Zetia

Ezetimibe/atorvastatin 10mg/10mg FDC

Drug

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

Other names: SCH 900068

Atorvastatin 10mg

Drug

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

Other names: Lipitor

Atorvastatin 80mg

Drug

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

Other names: Lipitor

Ezetimibe/atorvastatin 10mg/80mg FDC

Drug

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

Other names: SCH 900068

Primary outcomes

  1. Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin

    Time frame: Hour 0 to Hour 48

  2. Maximum plasma concentration (Cmax) of atorvastatin

    Time frame: Hour 0 to Hour 48

  3. Area under the concentration time-curves from time zero to the time of last measured concentration (AUC0-last) of unconjugated ezetimibe (EZ)

    Time frame: Hour 0 to Hour 96

  4. Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)

    Time frame: Hour 0 to Hour 96

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 8, 2010
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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