NCT01599377 - Tofacitinib Bioequivalence Study Comparing Tablets And Capsules | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions

Healthy

Interventions

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.

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.

Trial Locations (1)

188770

Pfizer Investigational Site, Singapore