Bioavailability Study for New Atorvastatin Formulation
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|ClinicalTrials.gov Identifier: NCT00844376|
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : October 21, 2009
Last Update Posted : October 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Drug: Atorvastatin suspension Drug: Lipitor||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Extemporaneous preparation suspension Atorvastatin prototype formulation
Drug: Atorvastatin suspension
A single dose of 80 mg Atorvastatin suspension
Commercial atorvastatin tablet (Lipitor®)
A single dose of 80 mg Lipitor tablet
Other Name: Atorvastatin
- 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).
- Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast) [ Time Frame: 5 days ]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
- Terminal Phase Rate Constant (Kel) [ Time Frame: 5 days ]Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).
- Time to Reach Maximum Plasma Concentration (Tmax) [ Time Frame: 5 days ]Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).
- Plasma Elimination Half-life (t1/2) [ Time Frame: 5 days ]Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844376
|United States, Connecticut|
|Pfizer Investigational Site|
|New Haven, Connecticut, United States, 06511|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|