Bioavailability Study for New Atorvastatin Formulation

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00844376
First received: February 13, 2009
Last updated: October 21, 2009
Last verified: July 2009
  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
Endpoint Classification: Bio-availability Study
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 ] [ Designated as safety issue: No ]
  • Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Terminal Phase Rate Constant (Kel) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Plasma Concentration (Tmax) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Plasma Elimination Half-life (t1/2) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Cardiovascular Diseases

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

ClinicalTrials.gov processed this record on October 21, 2014