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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.11 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ziprasidoneDRUG

40 mg capsule, single dose x 3

B16 FastedDRUG

40 mg tablet, single dose X 3

B16 FedDRUG

40 mg tablet, single dose X 3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects * Signed informed consent document Exclusion Criteria: * Any significant physical or psychological disease * Concomitant administration of other pharmaceuticals

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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

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

Time frame: 2 months

Data from ClinicalTrials.gov

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