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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014