A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01020136
First received: November 23, 2009
Last updated: April 21, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: AG-013736
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of single dose AG-013736 when administered as polymorph Forms XLI and IV in healthy volunteer [ Time Frame: 3 days per period ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: AG-013736
single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)
Experimental: 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
Drug: AG-013736
single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)

Detailed Description:

To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets

  Eligibility

Ages Eligible for Study:   21 Years to 47 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020136

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01020136     History of Changes
Other Study ID Numbers: A4061063
Study First Received: November 23, 2009
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioequivalence Pharmacokinetics

ClinicalTrials.gov processed this record on April 17, 2014