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Completed

NCT Number: NCT01119235

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.

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young
  • Healthy volunteers

Exclusion criteria

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

Treatment and study plan

PF-04531083

Drug

Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days

Primary outcomes

  1. concentration of PF-04531083 in blood just before dosing on the 8th day of the study

    Time frame: Days 1 and 8 of the study

Secondary outcomes

  1. pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.

    Time frame: Days 1, 8 and 14 of the study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 7, 2010
Registry last updated
Aug 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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