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Completed

NCT Number: NCT01599377

Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.

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Key information

Conditions

Healthy

Age range

21 year–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 (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, BP and PR measurement, 12 Lead ECG and clinical laboratory tests.

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Treatment and study plan

tofacitinib 10 mg

Drug

Cohort 1 will consist of 2 periods and 2 sequences. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 10 mg tofacitnib tablet under fasting conditions in period 1, followed by a 10 mg tofacitinib capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.

Tofacitinib 5 MG

Drug

Cohort 2 will consist of 2 periods and 2 sequences. A total of 24 healthy subjects will be enrolled for this cohort. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 5 mg tablet under fasting conditions in period 1, followed by a 5 mg capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.

Primary outcomes

  1. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf )

    Time frame: 24 hours

  2. Maximum plasma concentration (Cmax)

    Time frame: 24 hours

Secondary outcomes

  1. Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)

    Time frame: 24 hours

  2. Time for Cmax (Tmax)

    Time frame: 24 hours

  3. Terminal elimination half-life (t½)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1, Open-Label, Randomized, Single-Dose, Cross-Over, Bioequivalence Study Comparing Tablets (5 And 10 Mg) And Capsules (5 And 10 Mg) Of Tofacitinib Under Fasted Conditions In Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 16, 2012
Registry last updated
Jul 10, 2012

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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