A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Drug: PF-04531083

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119235

B1351005

Details and patient eligibility

About

A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Young
• Healthy volunteers

Exclusion criteria

• Elderly volunteers
• Patients with any existing medical conditions considered likely to impinge on study execution

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Cohort 1: PF-04531083

Active Comparator group

Treatment:

Drug: PF-04531083

Drug: PF-04531083

Cohort 2: PF-04531083

Active Comparator group

Treatment:

Drug: PF-04531083

Drug: PF-04531083