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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00821444
First received: January 9, 2009
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Healthy
Drug: ziprasidone
Drug: B16 Fasted
Drug: B16 Fed
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events reported, laboratory test results, vital signs observed with each study treatment [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  • Signed informed consent document

Exclusion Criteria:

  • Any significant physical or psychological disease
  • Concomitant administration of other pharmaceuticals
  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: NCT00821444

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
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: NCT00821444     History of Changes
Other Study ID Numbers: A1281191
Study First Received: January 9, 2009
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
schizophrenia, pharmacokinetics, bioavailability, food effect

Additional relevant MeSH terms:
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 18, 2014