NCT01388829CompletedPhase 1
A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of 2 Different Formulations Of PF-04991532
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Plasma AUClast
Study Overview
Brief Summary
This study is designed to compare the pharmacokinetics of two different lots of tablets.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
formulation comparison
Experimental
formulation comparison
Intervention: Treatment A (Drug)
formulation comparison
Experimental
formulation comparison
Intervention: Treatment B (Drug)
Outcomes
Primary Outcomes
Plasma AUClast
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
Plasma Cmax
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
Secondary Outcomes
- Plasma Tmax(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881Healthy VolunteersNCT04128787Agios Pharmaceuticals, Inc.36
Completed
Phase 1
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy AdultsBioequivalenceNCT05817435argenx120
Completed
Phase 1
Clinical Trial of Efepoetin Alfa in Healthy SubjectsHealthyNCT06490939Genexine, Inc.40
Completed
Phase 1
India Dexamethasone and BetamethasonePreterm BirthAntenatal CorticosteroidsNCT03668860Children's Hospital Medical Center, Cincinnati48
Completed
Phase 1
The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male VolunteersDiabetesHyperlipidemiaNCT02982798Jeil Pharmaceutical Co., Ltd.40