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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperlipidemia

Intervention: Ezetimibe (Drug); Ezetimibe/atorvastatin 10mg/10mg FDC (Drug); Atorvastatin 10mg (Drug); Atorvastatin 80mg (Drug); Ezetimibe/atorvastatin 10mg/80mg FDC (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Michael Seiberling, MD, Principal Investigator, Affiliation: Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the concentration-time-curve from time zero to infinity (AUC0-Ôł×) 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)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: February 2011
Last updated: December 30, 2014

Page last updated: August 23, 2015

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