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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01020136

Enrollment

Registered

2009-11-25

Start date

2010-01-31

Completion date

2010-02-28

Last updated

2010-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Bioequivalence Pharmacokinetics

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

Interventions

DRUGAG-013736

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 47 Years

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

Design outcomes

Primary

Measure	Time frame
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.	3 days per period

Secondary

Measure	Time frame
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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026