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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020136
• Other study ID #: A4061063
• Status: Completed
• Phase: Phase 1
• First received: November 23, 2009
• Last updated: April 21, 2010
• Start date: January 2010
• Est. completion date: February 2010

Study information

• Verified date: April 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 47 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AG-013736
single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)
• AG-013736
single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

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