Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: tofacitinib 10 mg; Drug: tofacitinib 5 mg

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf )	24 hours
Maximum plasma concentration (Cmax)	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)	24 hours
Time for Cmax (Tmax)	24 hours
Terminal elimination half-life (t½)	24 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 16, 2012

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 8, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921141