Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: tofacitinib 10 mg; Drug: tofacitinib 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01599377

A3921141

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Cohort 1

Experimental group

Treatment:

Drug: tofacitinib 10 mg

Cohort 2

Experimental group

Treatment:

Drug: tofacitinib 5 mg