Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

Sponsor
Pfizer
Study ID
NCT01599377
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
May 31, 2012
Status verified
Jul 2012
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2

Primary Outcome Measure

Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf ) [ Time Frame: 24 hours ]

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