A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01236430
First received: November 5, 2010
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia |
Drug: Ezetimibe Drug: Ezetimibe/atorvastatin 10mg/10mg FDC Drug: Atorvastatin 10mg Drug: Atorvastatin 80mg Drug: Ezetimibe/atorvastatin 10mg/80mg FDC |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551) |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin [ Time Frame: Hour 0 to Hour 48 ] [ Designated as safety issue: No ]
- Maximum plasma concentration (Cmax) of atorvastatin [ Time Frame: Hour 0 to Hour 48 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ) [ Time Frame: Hour 0 to Hour 96 ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | February 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Zetia
Drug: Atorvastatin 10mg
Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
Other Name: 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 Name: 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 Name: Zetia
Drug: Atorvastatin 80mg
Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
Other Name: 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 Name: SCH 900068
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01236430 History of Changes |
| Other Study ID Numbers: | P07551 |
| Study First Received: | November 5, 2010 |
| Last Updated: | October 16, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Merck:
|
Hyperlipidemia statin Ezetimibe |
Zetia Atorvastatin Lipitor |
Additional relevant MeSH terms:
|
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Ezetimibe Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013