HypercholesterolemiaPhase 4NCT00844376

Bioavailability Study for New Atorvastatin Formulation

A Phase 4 study testing Atorvastatin suspension and Lipitor in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation development. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia
What is being tested?: Atorvastatin suspension and Lipitor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Mar 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 male and/or female subjects
Body Mass Index (BMI) of approximately 18 to 30 kg/m2

Who cannot join

Any condition possibly affecting drug absorption
A positive urine drug screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: An Open Label, Single Dose, Randomized 2-Way Crossover Study To Estimate The Relative Bioavailability Of Atorvastatin Commercial Tablet, And An Extemporaneous Preparation (EP) Suspension Formulation, In Healthy Subjects

Read the detailed description

Estimation of Relative Bioavailability

Conditions: Hypercholesterolemia
Being tested: Atorvastatin suspension, Lipitor
Keywords: Cardiovascular Diseases
Medical subject headings: Hypercholesterolemia, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atorvastatin suspensionDrug
A single dose of 80 mg Atorvastatin suspension
LipitorDrug
Also called Atorvastatin
A single dose of 80 mg Lipitor tablet

Study groups in NCT00844376
Study group	Role	What they receive
Test	Other	Extemporaneous preparation suspension Atorvastatin prototype formulation Receives: Drug: Atorvastatin suspension
Reference	Other	Commercial atorvastatin tablet (Lipitor®) Receives: Drug: Lipitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)
Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus [vs] reference); measured in nanograms times hour per milliliter (ng.hr/mL).
Measured: 5 days
Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)
Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).
Measured: 5 days
Maximum Observed Plasma Concentration (Cmax)
Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).
Measured: 5 days

Secondary outcomes (4)

Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)
Geometric mean of AUClast = area under the plasma concentration-time curve from time zero (0) to the last measurable concentration of atorvastatin (test vs reference); measured as ng.hr/mL
Measured: 5 days
Terminal Phase Rate Constant (Kel)
Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).
Measured: 5 days
Time to Reach Maximum Plasma Concentration (Tmax)
Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).
Measured: 5 days
Plasma Elimination Half-life (t1/2)
Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.
Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Mar 2008

First posted16 Feb 2009 (estimated)
Study startFeb 2008
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypercholesterolemiaStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00844376
Sponsor's protocol ID: A2581164
Status last verified: Feb 2021
First submitted: 13 Feb 2009
Last updated: 10 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
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RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Single Dose, Randomized 2-Way Crossover Study To Estimate The Relative Bioavailability Of Atorvastatin Commercial Tablet, And An Extemporaneous Preparation (EP) Suspension Formulation, In Healthy Subjects
ClinicalTrials.gov ID: NCT00844376
Acronym / sponsor ID: A2581164
Conditions: Hypercholesterolemia
Keywords: Cardiovascular Diseases
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 16 Feb 2009 (estimated)
Results: Posted 21 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Estimation of Relative Bioavailability

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test	Other	Drug: Atorvastatin suspensionExtemporaneous preparation suspension Atorvastatin prototype formulation
Reference	Other	Drug: LipitorCommercial atorvastatin tablet (Lipitor®)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy male and/or female subjects
Body Mass Index (BMI) of approximately 18 to 30 kg/m2

Key exclusion criteria (2 listed)

Any condition possibly affecting drug absorption
A positive urine drug screening

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
Atorvastatin suspensionA single dose of 80 mg Atorvastatin suspension	Drug	Test
LipitorAlso: AtorvastatinA single dose of 80 mg Lipitor tablet	Drug	Reference

Primary outcome

Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)
Time frame: 5 days
Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus [vs] reference); measured in nanograms times hour per milliliter (ng.hr/mL).
Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)
Time frame: 5 days
Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 5 days
Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).

4 secondary outcomes

Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)
Time frame: 5 days
Terminal Phase Rate Constant (Kel)
Time frame: 5 days
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 5 days
Plasma Elimination Half-life (t1/2)
Time frame: 5 days

Results and safety

Results posted to the registry on 21 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Drug First (Atorvastatin EP Suspension)	6	5
Reference Drug First (Atorvastatin Tablet)	6	6

Primary outcome: Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)

Time frame: 5 days. Geometric mean (Full Range). Unit: ng.h/mL

Measure	Test n = 12	Reference n = 11
Value	135.05 (52.5 to 233.00)	140.79 (64.10 to 243.00)

Test vs Reference: ratio of adjusted geometric means: 95.77 (90% CI 85.82 to 106.88), Mixed Models Analysis

Primary outcome: Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)

Time frame: 5 days. Geometric mean (Full Range). Unit: ng.hr/mL

Measure	Test n = 12	Reference n = 11
Value	135.88 (51.20 to 234.00)	142.86 (65.00 to 247.00)

Test vs Reference: ratio of adjusted geometric means: 95.04 (90% CI 84.99 to 106.27), Mixed Models Analysis

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 5 days. Geometric mean (Full Range). Unit: ng/mL

Measure	Test n = 12	Reference n = 11
Value	38.74 (20.30 to 86.80)	33.24 (16.60 to 52.20)

Test vs Reference: ratio of adjusted geometric means: 117.90 (90% CI 98.22 to 141.53), Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Reference	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia

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.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atorvastatin suspension and Lipitor in people with Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.

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 2 inclusion and 2 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48) (time frame: 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00844376.

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 10 Mar 2021.