A Phase 1 Bioequivalence Study To Compare The Plasma Pharmacokinetics Of AG-013736 Polymorph Form IV Versus Market-Image Polymorph Form XLI Tablets In Healthy Volunteers Under Fed Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- To establish the bioequivalence of test 5 mg market-image tablets of AG-013736 polymorph Form XLI to reference 5 mg tablets of AG- 013736 polymorph Form IV under fed conditions.
Study Overview
Brief Summary
The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.
Detailed Description
To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 47 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and/or female subjects between the ages of 21 and 47 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 electrocardiogram (ECG) and clinical laboratory tests)
- •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 of significant disease of the blood, kidney, endocrine system, lungs, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding season allergies)
- •Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
- •Pregnant or nursing females and females of childbearing potential including those with tubal ligation
Arms & Interventions
Sequence 1 (BABA)
Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: B -> A -> B -> A
Intervention: AG-013736 (Drug)
Sequence 2 (ABAB)
Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: A -> B-> A -> B
Intervention: AG-013736 (Drug)
Outcomes
Primary Outcomes
To establish the bioequivalence of test 5 mg market-image tablets of AG-013736 polymorph Form XLI to reference 5 mg tablets of AG- 013736 polymorph Form IV under fed conditions.
Time Frame: 3 days per period
Secondary Outcomes
- To assess the safety and tolerability of single dose AG-013736 when administered as polymorph Forms XLI and IV in healthy volunteer(3 days per period)