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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821444

Enrollment

Registered

2009-01-13

Start date

2009-01-31

Completion date

2009-03-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

schizophrenia, pharmacokinetics, bioavailability, food effect

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.

Interventions

DRUGziprasidone

40 mg capsule, single dose x 3

DRUGB16 Fasted

40 mg tablet, single dose X 3

DRUGB16 Fed

40 mg tablet, single dose X 3

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects * Signed informed consent document

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse events reported, laboratory test results, vital signs observed with each study treatment	2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026