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Trial record 1 of 1 for:    NCT00821444
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Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules

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ClinicalTrials.gov Identifier: NCT00821444
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : April 13, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 9, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date April 13, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
Relative bioavailability measured as geometric mean ratios of AUCinf and Cmax and the associated 90% confidence intervals calculated for various pairs of study treatments. [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00821444 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
Adverse events reported, laboratory test results, vital signs observed with each study treatment [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
Adverse events reported, laboratory test results, vital signs observed with each study treatment. [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules
Official Title  ICMJE Phase 1 Study Of Ziprasidone Pharmacokinetics Of Reduced Food Effect Formulation B16 Under Fed And Fasting Conditions Compared To Commercial Geodon Capsules Under Fed Conditions In Healthy Subjects
Brief Summary Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ziprasidone
    40 mg capsule, single dose x 3
    Other Name: Geodon, Zeldox
  • Drug: B16 Fasted
    40 mg tablet, single dose X 3
  • Drug: B16 Fed
    40 mg tablet, single dose X 3
Study Arms  ICMJE
  • Active Comparator: Geodon fed
    Commercial Geodon (ziprasidone) capsules given with food
    Intervention: Drug: ziprasidone
  • Experimental: B16 Fasted
    Experimental reduced food effect formulation given without food
    Intervention: Drug: B16 Fasted
  • Experimental: B16 Fed
    Experimental reduced food effect formulation given with food
    Intervention: Drug: B16 Fed
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: March 19, 2009)
11
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2009)
24
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects
  • Signed informed consent document

Exclusion Criteria:

  • Any significant physical or psychological disease
  • Concomitant administration of other pharmaceuticals
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 NCT00821444
Other Study ID Numbers  ICMJE A1281191
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 April 2011

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