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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236430
• Other study ID #: P07551
• Status: Completed
• Phase: Phase 1
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time-curve from time zero to infinity (AUC0-8) of atorvastatin		Hour 0 to Hour 48
Primary	Maximum plasma concentration (Cmax) of atorvastatin		Hour 0 to Hour 48
Primary	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
Primary	Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)		Hour 0 to Hour 96