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

Last updated on May 10, 2018

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy subjects

- Signed informed consent document

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any significant physical or psychological disease

- Concomitant administration of other pharmaceuticals

NCT00821444
Pfizer
Completed
Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules

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Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules
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
Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects
  • Signed informed consent document

Exclusion Criteria:

  • Any significant physical or psychological disease
  • Concomitant administration of other pharmaceuticals
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00821444
A1281191
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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