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Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam

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ClinicalTrials.gov Identifier: NCT00427505
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : November 19, 2009
Sponsor:
Information provided by:
Novartis

Brief Summary:
This is a study to investigate the pharmacokinetics of deferasirox

Condition or disease Intervention/treatment Phase
Healthy Drug: Deferasirox Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers
Study Start Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To assess the effect of deferasirox on the pharmacokinetics of midazolam

Secondary Outcome Measures :
  1. Safety assessed by adverse events (AEs)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good health
  • No evidence of iron deficiency
  • Weight between 50 and 100 kg
  • Body Mass Index between 19 and 29 kg/m2

Exclusion Criteria:

  • Use of certain drugs, herbal remedies or nutrients

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427505


Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis

Responsible Party: e, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00427505     History of Changes
Other Study ID Numbers: CICL670A2126
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

Keywords provided by Novartis:
Interaction
healthy volunteers
deferasirox
midazolam

Additional relevant MeSH terms:
Midazolam
Deferasirox
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Chelating Agents
Sequestering Agents