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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: B16 Fed; Drug: B16 Fasted; Drug: ziprasidone

• Registration Number: NCT00821444
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Healthy subjects
• Signed informed consent document

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B16 Fed	B16 Fed	Experimental reduced food effect formulation given with food
B16 Fasted	B16 Fasted	Experimental reduced food effect formulation given without food
Geodon fed	ziprasidone	Commercial Geodon (ziprasidone) capsules given with food

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States