Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599377
• Other study ID #: A3921141
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2012
• Last updated: July 8, 2012
• Start date: May 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf )		24 hours	No
Primary	Maximum plasma concentration (Cmax)		24 hours	No
Secondary	Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)		24 hours	No
Secondary	Time for Cmax (Tmax)		24 hours	No
Secondary	Terminal elimination half-life (t½)		24 hours	No

External Links

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