Skip to main content
OpenTrials
Completed

NCT Number: NCT01020136

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

21 year–47 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AG-013736

Drug

single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2009
Registry last updated
Apr 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.