A Drug-drug Interaction Study of Oral 1250 mg of Vatalinib Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor in Healthy Sterile or Postmenopausal Female Volunteers
This study has been completed.
Information provided by:
First received: January 23, 2007
Last updated: November 18, 2009
Last verified: November 2009
This study will determine the effect of acidic drugs such as proton-pump inhibitors on the pharmacokinetics of Vatalinib under fasting and fed conditions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Assess the effect of multiple doses of a proton-pump inhibitor on the pharmacokinetics of a single dose of Vatalinib under fasting and fed conditions.
Secondary Outcome Measures:
- Safety of a single dose of Vatalinib before and after a proton-pump inhibitor under fasting and fed conditions as assessed by adverse events, laboratory values, electrocardiograms, and vital signs.
|Study Start Date:||July 2006|
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