Effect of Food on Bioavailability of Modified Release Formulations of Imatinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420043
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : April 5, 2016
Information provided by (Responsible Party):

January 8, 2007
January 9, 2007
April 5, 2016
September 2006
November 2006   (Final data collection date for primary outcome measure)
To compare the bioavailability of Modified Release formulations to 400 mg immediate release (IR) tablet when administered twice-daily (both given with a low fat meal).
Same as current
Complete list of historical versions of study NCT00420043 on Archive Site
  • To compare the relative bioavailability of a single daily 800 mg dose of modified release formulations with a high fat meal and a low fat (regular) meal, to modified release formulations after over-night fasting in healthy volunteers.
  • To compare safety and tolerability of the 800 mg daily dose modified release formulations with or without food
Same as current
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Effect of Food on Bioavailability of Modified Release Formulations of Imatinib
A Phase I, Two Arm, Open-label, Randomized, Study to Investigate the Effect of Food on the Bioavailability of a Single 800 mg Imatinib Dose in Modified Release Formulations (MR3 and MR4) and Compare the Bioavailability Between MR3, MR4 and Imatinib 400 mg Twice Daily Immediate Release Tablet (IR) in Healthy Subjects
This study will evaluate the effect of food on the relative bioavailability of a single dose of imatinib given as a 800 mg modified release tablet, compared to twice-daily doses of 400 mg film-coated tablets. There will be a 8 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments.
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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: imatinib
Other Name: STI571
  • Experimental: imatinib 800mg
    Intervention: Drug: imatinib
  • Active Comparator: imatinib 400mg
    Intervention: Drug: imatinib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2006
November 2006   (Final data collection date for primary outcome measure)

Inclusion criteria

  • Healthy male or female subjects (postmenopausal women), 18-65 years of age
  • Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

  • Smokers within 3 months
  • Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 3 weeks prior to dosing.
  • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
  • A past medical history or presence of clinically significant ECG abnormalities
  • History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
  • History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
  • Women taking any biphosphonates (Fosomax like drugs)
  • History of being immunocompromised, including a positive HIV test result.
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
  • Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Novartis Pharmaceuticals Novartis
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP