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Trial record 51 of 730 for:    Area Under Curve AND Bioavailability

Bioavailability Study for New Atorvastatin Formulation

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.
 
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:
Pfizer

Tracking Information
First Submitted Date  ICMJE February 13, 2009
First Posted Date  ICMJE February 16, 2009
Results First Submitted Date  ICMJE March 5, 2009
Results First Posted Date  ICMJE October 21, 2009
Last Update Posted Date October 28, 2009
Study Start Date  ICMJE February 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2009)
Primary endpoints are the comparison of Cmax, AUCinf and AUC48 of atorvastatin between the commercial tablet (reference) and the prototype formulation (test). [ Time Frame: 1 month ]
Change History Complete list of historical versions of study NCT00844376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2009)
Secondary endpoints are other PK parameters (AUClast, Tmax, Kel and t1/2), and safety assessments based on adverse events. [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study for New Atorvastatin Formulation
Official Title  ICMJE 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
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.
Detailed Description Estimation of Relative Bioavailability
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: Atorvastatin suspension
    A single dose of 80 mg Atorvastatin suspension
  • Drug: Lipitor
    A single dose of 80 mg Lipitor tablet
    Other Name: Atorvastatin
Study Arms  ICMJE
  • Test
    Extemporaneous preparation suspension Atorvastatin prototype formulation
    Intervention: Drug: Atorvastatin suspension
  • Reference
    Commercial atorvastatin tablet (Lipitor®)
    Intervention: Drug: Lipitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2009)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00844376
Other Study ID Numbers  ICMJE A2581164
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP