Bioavailability Study for New Atorvastatin Formulation

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Atorvastatin suspension; Drug: Lipitor

Detailed Description

Estimation of Relative Bioavailability

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Test; Extemporaneous preparation suspension Atorvastatin prototype formulation	Drug: Atorvastatin suspension; A single dose of 80 mg Atorvastatin suspension
Other: Reference; Commercial atorvastatin tablet (Lipitor®)	Drug: Lipitor; A single dose of 80 mg Lipitor tablet; Other Names: Atorvastatin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 13, 2009
• First Posted (Estimate): February 16, 2009

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: A2581164