HyperlipidemiaPhase 1NCT01236430
A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
A Phase 1 study testing Ezetimibe, Ezetimibe/atorvastatin 10mg/10mg FDC and Atorvastatin 10mg in people with Hyperlipidemia, run by Organon and Co.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Ezetimibe, Ezetimibe/atorvastatin 10mg/10mg FDC and Atorvastatin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Hyperlipidemia
- Being tested
- Ezetimibe, Ezetimibe/atorvastatin 10mg/10mg FDC, Atorvastatin 10mg, Atorvastatin 80mg, Ezetimibe/atorvastatin 10mg/80mg FDC
- Keywords
- Hyperlipidemia, statin, Ezetimibe, Zetia, Atorvastatin, Lipitor
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Also called Zetia
Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
Ezetimibe/atorvastatin 10mg/10mg FDCDrug
Also called SCH 900068
Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
Atorvastatin 10mgDrug
Also called Lipitor
Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
Atorvastatin 80mgDrug
Also called Lipitor
Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
Ezetimibe/atorvastatin 10mg/80mg FDCDrug
Also called SCH 900068
Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe 10mg and Atorvastatin 10mg | Active comparator | Ezetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered Receives: Drug: Ezetimibe; Drug: Atorvastatin 10mg |
| 10mg Ezetimibe/10mg Atorvastatin | Experimental | 10mg Ezetimibe/10mg atorvastatin combination tablet Receives: Drug: Ezetimibe/atorvastatin 10mg/10mg FDC |
| Ezetimibe 10mg and Atorvastatin 80mg | Active comparator | Ezetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered Receives: Drug: Ezetimibe; Drug: Atorvastatin 80mg |
| 10mg Ezetimibe/80mg Atorvastatin | Experimental | Ezetimibe/atorvastatin 10mg/80mg combination tablet Receives: Drug: Ezetimibe/atorvastatin 10mg/80mg FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin
Measured: Hour 0 to Hour 48
Maximum plasma concentration (Cmax) of atorvastatin
Measured: 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)
Measured: Hour 0 to Hour 96
Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)
Measured: Hour 0 to Hour 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Seiberling, MD, Principal investigator, Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236430
- Sponsor's protocol ID
- P07551
- Status last verified
- Feb 2022
- First submitted
- 5 Nov 2010
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Definitive Bioequivalence of SCH 900068 With Marketed Products (Protocol No. P07551)
- ClinicalTrials.gov ID
- NCT01236430
- Acronym / sponsor ID
- P07551
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, statin, Ezetimibe, Zetia, Atorvastatin, Lipitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe 10mg and Atorvastatin 10mg | Active comparator | Drug: Ezetimibe, Drug: Atorvastatin 10mgEzetimibe 10mg tablet and Atorvastatin 10mg tablet coadministered |
| 10mg Ezetimibe/10mg Atorvastatin | Experimental | Drug: Ezetimibe/atorvastatin 10mg/10mg FDC10mg Ezetimibe/10mg atorvastatin combination tablet |
| Ezetimibe 10mg and Atorvastatin 80mg | Active comparator | Drug: Ezetimibe, Drug: Atorvastatin 80mgEzetimibe 10mg tablet and Atorvastatin 80mg tablet coadministered |
| 10mg Ezetimibe/80mg Atorvastatin | Experimental | Drug: Ezetimibe/atorvastatin 10mg/80mg FDCEzetimibe/atorvastatin 10mg/80mg combination tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EzetimibeAlso: ZetiaEzetimibe 10mg tablet given orally after an overnight fast (at least 10 hours). | Drug | Ezetimibe 10mg and Atorvastatin 10mg, Ezetimibe 10mg and Atorvastatin 80mg |
| Ezetimibe/atorvastatin 10mg/10mg FDCAlso: SCH 900068Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours). | Drug | 10mg Ezetimibe/10mg Atorvastatin |
| Atorvastatin 10mgAlso: LipitorAtorvastatin 10mg given orally after an overnight fast (at least 10 hours). | Drug | Ezetimibe 10mg and Atorvastatin 10mg |
| Atorvastatin 80mgAlso: LipitorAtorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours). | Drug | Ezetimibe 10mg and Atorvastatin 80mg |
| Ezetimibe/atorvastatin 10mg/80mg FDCAlso: SCH 900068Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours). | Drug | 10mg Ezetimibe/80mg Atorvastatin |
Primary outcome
Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin
Time frame: Hour 0 to Hour 48
Maximum plasma concentration (Cmax) of atorvastatin
Time frame: 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
Maximum plasma concentration (Cmax) of unconjugated ezetimibe (EZ)
Time frame: Hour 0 to Hour 96
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Seiberling, MD principal investigator
Covance Clinical Research Unit AG, Lettenweg 118, CH-4123 Allschwil (Basel), Switzerland
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ezetimibe, Ezetimibe/atorvastatin 10mg/10mg FDC and Atorvastatin 10mg in people with Hyperlipidemia, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time-curve from time zero to infinity (AUC0-∞) of atorvastatin (time frame: Hour 0 to Hour 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.