OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05221304 Formulation A; Drug: PF-05221304 Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT03871439

C1171007

Details and patient eligibility

About

The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages of 18 and 55 years old inclusive
• Body Mass Index (BMI) of >= 17.5 and <= 30.4 kg/m2
• Total body weight > 50 kg (110lb)

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

PF-05221304 Formulation A

Experimental group

Treatment:

Drug: PF-05221304 Formulation A

PF-05221304 Formulation B

Experimental group

Treatment:

Drug: PF-05221304 Formulation B