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

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ziprasidone; Drug: B16 Fed; Drug: B16 Fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821444

A1281191

Details and patient eligibility

About

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

Enrollment: 11 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects
• Signed informed consent document

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Geodon fed

Active Comparator group

Description:

Commercial Geodon (ziprasidone) capsules given with food

Treatment:

Drug: ziprasidone

B16 Fasted

Experimental group

Description:

Experimental reduced food effect formulation given without food

Treatment:

Drug: B16 Fasted

B16 Fed

Experimental group

Description:

Experimental reduced food effect formulation given with food

Treatment:

Drug: B16 Fed