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Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

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ClinicalTrials.gov Identifier: NCT01599377
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Drug: tofacitinib 10 mg Drug: tofacitinib 5 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : May 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 Drug: tofacitinib 10 mg
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.

Experimental: Cohort 2 Drug: tofacitinib 5 mg
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599377


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01599377     History of Changes
Other Study ID Numbers: A3921141
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action