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Sponsors and Collaborators: |
Novartis Bayer |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00426452 |
This study will determine the effect of acidic drugs such as proton-pump inhibitors on the pharmacokinetics of Vatalinib under fasting and fed conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Vatalinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Phase IB, Open Label, Single Center, Drug-Drug Interaction Study of Oral 1250 mg of PTK787/ZK 222584 Administered Under Fasting and Fed Conditions With a Proton-Pump Inhibitor (Omeprazole) in Healthy Sterile or Postmenopausal Female Volunteers |
Estimated Enrollment: | 24 |
Study Start Date: | July 2006 |
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Female |
Inclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CPTK787A2121 |
Study First Received: | January 23, 2007 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00426452 |
Health Authority: | United States: Food and Drug Administration |
Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor Vatalinib Proton-pump inhibitors Omeprazole Healthy Postmenopausal Female Volunteers |
Omeprazole Healthy Endothelial Growth Factors Vatalanib |