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Completed

NCT Number: NCT01185184

Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers

This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.

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Key information

Conditions

Healthy

Age range

21 month–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and/or female subjects

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Clinically significant infections within the past 3 months.

Treatment and study plan

CP-690,550

Drug

Single doses separated by a minimum of 72 hour washout between treatments

Primary outcomes

  1. Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550

    Time frame: 36 hours

Secondary outcomes

  1. Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550

    Time frame: 9 days

  2. Safety: laboratory tests, adverse events reporting, ECG and vital signs

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, 3-Period, Open Label, Single Dose, Cross Over Study To Evaluate The Pharmacokinetics And Safety Of Two Controlled Release Formulations Of CP-690,550

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 19, 2010
Registry last updated
Sep 14, 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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