You are here

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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-47 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01020136
Pfizer
Completed
A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
NCT02743871
All Genders
18+
Years
Multiple Sites
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
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.
To establish bioequivalence between Form IV and Form XLI of AG-013736 tablets
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Volunteer
Drug: AG-013736
single oral dose 5-mg tablet (Form IV for Treatment A and Form XLI for Treatment B under fed conditions)
  • Experimental: Sequence 1 (BABA)
    Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: B -> A -> B -> A
    Intervention: Drug: AG-013736
  • Experimental: Sequence 2 (ABAB)
    Treatment A: 5-mg Form IV tablet; Treatment B: 5-mg Form XLI tablets Subjects in this sequence will participate in 4 periods in the following order: A -> B-> A -> B
    Intervention: Drug: AG-013736
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2010
February 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 47 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01020136
A4061063
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now