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Bioavailability Study for New Atorvastatin Formulation

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ClinicalTrials.gov Identifier: NCT00844376
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : October 21, 2009
Last Update Posted : October 28, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Atorvastatin suspension Drug: Lipitor Phase 4

Detailed Description:
Estimation of Relative Bioavailability

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : February 2008
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: February 16, 2009    Key Record Dates
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