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OpenTrials
Completed

NCT Number: NCT00821444

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

Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.

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Key information

Conditions

Healthy Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects
  • Signed informed consent document

Exclusion criteria

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

Treatment and study plan

Ziprasidone

Drug

40 mg capsule, single dose x 3

Other names: Geodon, Zeldox

B16 Fasted

Drug

40 mg tablet, single dose X 3

B16 Fed

Drug

40 mg tablet, single dose X 3

Primary outcomes

  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 outcomes

  1. Adverse events reported, laboratory test results, vital signs observed with each study treatment

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2009
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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