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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00427505
First received: January 25, 2007
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

This is a study to investigate the pharmacokinetics of deferasirox


Condition Intervention Phase
Healthy
 Drug: Deferasirox
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 22
Study Start Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427505

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided

Responsible Party: e, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00427505     History of Changes
Other Study ID Numbers: CICL670A2126
Study First Received: January 25, 2007
Last Updated: November 18, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Interaction
healthy volunteers
deferasirox
midazolam

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

ClinicalTrials.gov processed this record on May 23, 2013