Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00847418
First received: February 18, 2009
Last updated: December 1, 2010
Last verified: December 2010
  Purpose

The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.


Condition Intervention Phase
Pain
Drug: esketamine hydrochloride
Phase 1

Study Type: Interventional
Official Title: Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

Further study details as provided by University Hospital, Basel, Switzerland:

Study Start Date: February 2009
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: Esketamine Drug: esketamine hydrochloride

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847418

Locations
Switzerland
Clinical Research Center, University Hospital Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Manuel Haschke, MD Clinical Pharmacology and Toxicology, University Hospital Basel
  More Information

No publications provided

Responsible Party: Qualified Person, Stefanie Deuster, PhD., Hospital Pharmacy, University Hospital Basel, Switzerland.
ClinicalTrials.gov Identifier: NCT00847418     History of Changes
Other Study ID Numbers: EKBB 351/08, 2009DR1015
Study First Received: February 18, 2009
Last Updated: December 1, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
pharmacokinetics
ketamine
Anesthetics, Dissociative

Additional relevant MeSH terms:
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014