Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

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.
 
ClinicalTrials.gov Identifier: NCT00847418
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : December 2, 2010
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE February 18, 2009
First Posted Date  ICMJE February 19, 2009
Last Update Posted Date December 2, 2010
Study Start Date  ICMJE February 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Official Title  ICMJE Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Brief Summary The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Not Provided
Condition  ICMJE Pain
Intervention  ICMJE Drug: esketamine hydrochloride
Study Arms  ICMJE Experimental: Esketamine
Intervention: Drug: esketamine hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00847418
Other Study ID Numbers  ICMJE EKBB 351/08, 2009DR1015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qualified Person, Stefanie Deuster, PhD., Hospital Pharmacy, University Hospital Basel, Switzerland.
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manuel Haschke, MD Clinical Pharmacology and Toxicology, University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2010

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