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CompletedNCT00905814Updated Nov 16, 2009

A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

A Phase 1 interventional study of AG-013736 and AG-103736 in Healthy Volunteers, sponsored by Pfizer. Completed at 1 site in Singapore. Open to participants aged 21 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-11-16.

Sponsored by Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
21 Years to 47 Years
Sex
All
01

Study summary

The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Bioequivalence
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 47 Years
Sexes eligible
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

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).
  • Active smokers or users of tobacco containing products and other drugs
  • Pregnant or nursing females; females of childbearing potential including those with tubal ligation.
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    Sequence 1 (BABA)

    Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: B -\> A -\> B -\> A

    Drug: AG-013736

  • Other
    Sequence 2 (ABAB)

    Treatment A: One 5-mg FCIR tablet Treatment B: Five 1-mg FCIR tablets Subjects in this sequence will participate in 4 periods in the following order: A -\> B -\> A -\> B

    Drug: AG-103736

Interventions

  • DrugAG-013736

    single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)

    Also known as: axitinib

  • DrugAG-103736

    single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)

    Also known as: axitinib

06

What researchers measure

Primary outcomes

  1. To establish bioequivalence of five 1 mg film coated immediate release (FCIR) tablets of AG-013736 to one 5 mg FCIR tablet of AG-013736.

    Time frame: 3 days per period

Secondary outcomes

  1. To assess the safety and tolerability of single dose AG-013736 when administered as five 1 mg FCIR tablets and one 5 mg FCIR tablet.

    Time frame: 3 days per period

07

Study locations

1 site
  • Pfizer Investigational Site
    Singapore, 188770, Singapore
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00905814
Lead sponsor
Pfizer
First posted
May 21, 2009
Start date
Jul 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Nov 16, 2009

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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