Back to results

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

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Ezetimibe

Ezetimibe/atorvastatin 10mg/10mg FDC

Atorvastatin 10mg

Atorvastatin 80mg

Ezetimibe/atorvastatin 10mg/80mg FDC

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Hyperlipidemia, statin, Ezetimibe, Zetia, Atorvastatin, Lipitor

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Ezetimibe 10mg and Atorvastatin 10mg

10mg Ezetimibe/10mg Atorvastatin

Ezetimibe 10mg and Atorvastatin 80mg

10mg Ezetimibe/80mg Atorvastatin

Arm Description

Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered

10mg Ezetimibe/10mg atorvastatin combination tablet

Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered

Ezetimibe/atorvastatin 10mg/80mg combination tablet

Outcomes

Primary Outcome Measures

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

Maximum plasma concentration (Cmax) of atorvastatin

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01236430

First Posted

November 5, 2010

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT01236430

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemia

Keywords

Hyperlipidemia, statin, Ezetimibe, Zetia, Atorvastatin, Lipitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ezetimibe 10mg and Atorvastatin 10mg

Arm Type

Active Comparator

Arm Description

Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered

Arm Title

10mg Ezetimibe/10mg Atorvastatin

Arm Type

Experimental

Arm Description

10mg Ezetimibe/10mg atorvastatin combination tablet

Arm Title

Ezetimibe 10mg and Atorvastatin 80mg

Arm Type

Active Comparator

Arm Description

Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered

Arm Title

10mg Ezetimibe/80mg Atorvastatin

Arm Type

Experimental

Arm Description

Ezetimibe/atorvastatin 10mg/80mg combination tablet

Intervention Type

Drug

Intervention Name(s)

Ezetimibe

Other Intervention Name(s)

Zetia

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ezetimibe/atorvastatin 10mg/10mg FDC

Other Intervention Name(s)

SCH 900068

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 10mg

Other Intervention Name(s)

Lipitor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 80mg

Other Intervention Name(s)

Lipitor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ezetimibe/atorvastatin 10mg/80mg FDC

Other Intervention Name(s)

SCH 900068

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Hour 0 to Hour 48

Title

Maximum plasma concentration (Cmax) of atorvastatin

Time Frame

Hour 0 to Hour 48

Title

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

Title

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

Time Frame

Hour 0 to Hour 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Seiberling, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs