We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 18, 2009
First Posted: February 19, 2009
Last Update Posted: December 2, 2010
Last Verified: December 2010

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