A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers

NCT00905814 | Completed Phase 1

• 1 other identifier: A4061052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Bioequivalence

Outcome Measures

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.

  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.

  3 days per period

Study Arms (2)

Sequence 1 (BABA)

OTHER

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

Sequence 2 (ABAB)

OTHER

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

AG-013736 DRUG

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

Sequence 1 (BABA)

AG-103736 DRUG

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

Sequence 2 (ABAB)

Eligibility Criteria

• Age: 21 Years - 47 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 16, 2009

Record last verified: 2009-11

Locations

SG (1)