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

February 7, 2022 updated by: Organon and Co

A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin
Time Frame: Hour 0 to Hour 48
Hour 0 to Hour 48
Maximum plasma concentration (Cmax) of atorvastatin
Time Frame: Hour 0 to Hour 48
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)
Time Frame: Hour 0 to Hour 96
Hour 0 to Hour 96
Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)
Time Frame: Hour 0 to Hour 96
Hour 0 to Hour 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Investigators

  • Principal Investigator: Michael Seiberling, MD, Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 7, 2010

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P07551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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