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Bioavailability Study for New Atorvastatin Formulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00844376
First Posted: February 16, 2009
Last Update Posted: October 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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: 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

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
Test
Extemporaneous preparation suspension Atorvastatin prototype formulation
Drug: Atorvastatin suspension
A single dose of 80 mg Atorvastatin suspension
Reference
Commercial atorvastatin tablet (Lipitor®)
Drug: Lipitor
A single dose of 80 mg Lipitor tablet
Other Name: Atorvastatin

Detailed Description:
Estimation of Relative Bioavailability
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

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


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00844376     History of Changes
Other Study ID Numbers: A2581164
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: March 5, 2009
Results First Posted: October 21, 2009
Last Update Posted: October 28, 2009
Last Verified: July 2009

Keywords provided by Pfizer:
Cardiovascular Diseases

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors