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Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847418
First Posted: February 19, 2009
Last Update Posted: December 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Basel, Switzerland
February 18, 2009
February 19, 2009
December 2, 2010
February 2009
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Complete list of historical versions of study NCT00847418 on ClinicalTrials.gov Archive Site
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Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.
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Interventional
Phase 1
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Pain
Drug: esketamine hydrochloride
Experimental: Esketamine
Intervention: Drug: esketamine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2009
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Inclusion Criteria:

  • male
  • age ≥18 years ≤ 45 years
  • healthy
  • non-smoking
  • BMI 18-27

Exclusion Criteria:

  • abuse of drugs
  • known or supposed hypersensitivity and/or contraindication against ketamine or additives
  • participation of another clinical study within the last 30 days
  • chronic obstructed nose breathing or nasal polyps
  • dug allergy
  • blood donation within the last two months
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00847418
EKBB 351/08, 2009DR1015
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Qualified Person, Stefanie Deuster, PhD., Hospital Pharmacy, University Hospital Basel, Switzerland.
University Hospital, Basel, Switzerland
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Principal Investigator: Manuel Haschke, MD Clinical Pharmacology and Toxicology, University Hospital Basel
University Hospital, Basel, Switzerland
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP