NCT00821444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

January 9, 2009

Last Update Submit

February 18, 2021

Conditions

Healthy

Keywords

schizophrenia, pharmacokinetics, bioavailability, food effect

Outcome Measures

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.

    2 months

Secondary Outcomes (1)

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

    2 months

Study Arms (3)

Geodon fed

ACTIVE COMPARATOR

Commercial Geodon (ziprasidone) capsules given with food

Drug: ziprasidone

B16 Fasted

EXPERIMENTAL

Experimental reduced food effect formulation given without food

Drug: B16 Fasted

B16 Fed

EXPERIMENTAL

Experimental reduced food effect formulation given with food

Drug: B16 Fed

Interventions

ziprasidoneDRUG

40 mg capsule, single dose x 3

Also known as: Geodon, Zeldox
Geodon fed
B16 FastedDRUG

40 mg tablet, single dose X 3

B16 Fasted
B16 FedDRUG

40 mg tablet, single dose X 3

B16 Fed

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Signed informed consent document

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 13, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

US(1)