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Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules

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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ziprasidone Drug: B16 Fasted Drug: B16 Fed Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Geodon fed
Commercial Geodon (ziprasidone) capsules given with food
Drug: ziprasidone
40 mg capsule, single dose x 3
Other Name: Geodon, Zeldox

Experimental: B16 Fasted
Experimental reduced food effect formulation given without food
Drug: B16 Fasted
40 mg tablet, single dose X 3

Experimental: B16 Fed
Experimental reduced food effect formulation given with food
Drug: B16 Fed
40 mg tablet, single dose X 3

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Adverse events reported, laboratory test results, vital signs observed with each study treatment [ Time Frame: 2 months ]

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

Inclusion Criteria:

  • Healthy subjects
  • Signed informed consent document

Exclusion Criteria:

  • Any significant physical or psychological disease
  • Concomitant administration of other pharmaceuticals

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 identifier (NCT number): NCT00821444

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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00821444    
Other Study ID Numbers: A1281191
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: April 2011
Keywords provided by Pfizer:
schizophrenia, pharmacokinetics, bioavailability, food effect
Additional relevant MeSH terms:
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Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents