Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
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|ClinicalTrials.gov Identifier: NCT00917579|
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : October 14, 2009
Last Update Posted : March 12, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Drug: Atorvastatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet In Healthy Subjects|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
10 mg atorvastatin
A single 10 mg dose of marketed 10 mg atorvastatin tablets
New 10 mg atorvastatin tablet
A single 10 mg dose of new formulation of 10 mg atorvastatin
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose ]AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose ]AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose ]Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).
- Time to Reach Maximum Plasma Concentration (Tmax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose ]Tmax = time (hours) to maximum plasma concentration (Cmax).
- Plasma Elimination Half-life (t1/2) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose ]t1/2 = terminal elimination half-life in hours.
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Healthy male and/or female subjects between the ages of 18 and 55 years
- Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
- Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.
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): NCT00917579
|United States, Florida|
|Pfizer Investigational Site|
|Miami, Florida, United States, 33169|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|
|Responsible Party:||Pfizer's Upjohn has merged with Mylan to form Viatris Inc.|
|Other Study ID Numbers:||
|First Posted:||June 10, 2009 Key Record Dates|
|Results First Posted:||October 14, 2009|
|Last Update Posted:||March 12, 2021|
|Last Verified:||February 2021|
Bioequivalence, pharmacokinetics, atorvastatin
Lipid Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors