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Bioavailability Study for New Atorvastatin Formulation

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: February 13, 2009
Last updated: October 21, 2009
Last verified: July 2009
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.

Condition Intervention Phase
Hypercholesterolemia Drug: Atorvastatin suspension Drug: Lipitor Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48) [ Time Frame: 5 days ]
  • Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity) [ Time Frame: 5 days ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast) [ Time Frame: 5 days ]
  • Terminal Phase Rate Constant (Kel) [ Time Frame: 5 days ]
  • Time to Reach Maximum Plasma Concentration (Tmax) [ Time Frame: 5 days ]
  • Plasma Elimination Half-life (t1/2) [ Time Frame: 5 days ]

Enrollment: 12
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Extemporaneous preparation suspension Atorvastatin prototype formulation
Drug: Atorvastatin suspension
A single dose of 80 mg Atorvastatin suspension
Commercial atorvastatin tablet (Lipitor®)
Drug: Lipitor
A single dose of 80 mg Lipitor tablet
Other Name: Atorvastatin

Detailed Description:
Estimation of Relative Bioavailability

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00844376

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00844376     History of Changes
Other Study ID Numbers: A2581164
Study First Received: February 13, 2009
Results First Received: March 5, 2009
Last Updated: October 21, 2009

Keywords provided by Pfizer:
Cardiovascular Diseases

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 16, 2017