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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.
Estimation of Relative Bioavailability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Other | Extemporaneous preparation suspension Atorvastatin prototype formulation |
|
| Reference | Other | Commercial atorvastatin tablet (Lipitor®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin suspension | Drug | A single dose of 80 mg Atorvastatin suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 days |
| Terminal Phase Rate Constant (Kel) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This study contained two sequences of 6 subjects per sequence. Each sequence received either test treatment followed by reference treatment, or reference treatment followed by test treatment. The order of administration was randomized to either of 2 sequences.
One center in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Drug First (Atorvastatin EP Suspension) | 80-milligram (mg) Extemporaneous preparation (EP) suspension atorvastatin prototype formulation as a single dose in the first intervention period and commercial (reference) 80 mg atorvastatin tablet (Lipitor®) as a single dose in the second intervention period. Period 2 began immediately after period 1. |
| FG001 | Reference Drug First (Atorvastatin Tablet) | 80-mg Commercial atorvastatin tablet (Lipitor®) as a single dose in the first intervention period and 80-mg EP suspension atorvastatin prototype formulation as a single dose in the second intervention period. Period 2 began immediately after period 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention |
|
| ||||||||||||||||||
| Period 2: Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Geometric Mean | Full Range | ng.h/mL | 5 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | 80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Lipitor |
| Drug |
A single dose of 80 mg Lipitor tablet |
|
|
Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr). |
| 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). | 5 days |
| Plasma Elimination Half-life (t1/2) | Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours. | 5 days |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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). | Posted | Geometric Mean | Full Range | ng.hr/mL | 5 days |
|
|
|
|
| Secondary | 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 | Posted | Geometric Mean | Full Range | ng.hr/mL | 5 days |
|
|
|
|
| Primary | 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). | Posted | Geometric Mean | Full Range | ng/mL | 5 days |
|
|
|
|
| Secondary | 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). | Posted | Geometric Mean | Full Range | 1/hr | 5 days |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) | Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr). | Posted | Median | Full Range | hr | 5 days |
|
|
|
| Secondary | Plasma Elimination Half-life (t1/2) | Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours. | Posted | Mean | Standard Deviation | hr | 5 days |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Reference | 80-mg Commercial atorvastatin tablet (Lipitor®) | 0 | 11 | 1 | 11 |
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009750 |
| Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |