Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Treatment B

Drug: Treatment A

Study type

Interventional

Funder types

Industry

Identifiers

B2611015

Details and patient eligibility

About

This study is designed to compare the pharmacokinetics of two different lots of tablets.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement [confirmed by a single repeat, if necessary] following at least 5 minutes of rest.
Any condition possibly affecting drug absorption (eg, gastrectomy).