Bioavailability Study for New Atorvastatin Formulation

Study Overview
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Brief Summary
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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.

Detailed Description
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Estimation of Relative Bioavailability

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Atorvastatin suspension
* Drug: Lipitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects Body Mass Index (BMI) of approximately 18 to 30 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption A positive urine drug screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test<br>Extemporaneous preparation suspension Atorvastatin prototype formulation | Drug: Atorvastatin suspension<br>* A single dose of 80 mg Atorvastatin suspension<br>|
| Other: Reference<br>Commercial atorvastatin tablet (Lipitor®) | Drug: Lipitor<br>* A single dose of 80 mg Lipitor tablet<br>* Other names: Atorvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases