Status:
COMPLETED
Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief Summary
This is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800 mg modified re...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Healthy male or female subjects (postmenopausal women)
- Able to communicate well with the investigator and comply with the requirements of the study.
- Exclusion criteria
- Smokers
- Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 2 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 including:
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00422825
Start Date
June 1 2006
End Date
September 1 2006
Last Update
April 5 2016
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