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Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

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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

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

Condition or disease Intervention/treatment Phase
Pain Drug: esketamine hydrochloride Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Study Start Date : February 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: Esketamine Drug: esketamine hydrochloride




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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

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

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 Posted: February 19, 2009    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: December 2010

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