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Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT00847418
Collaborator
(none)
1
Location
1
Arm
8
Duration (Months)

Study Details

Study Description

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
  • Drug: esketamine hydrochloride
 Phase 1

Study Design

Study Type:
Interventional
Official Title:
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
Study Start Date :
Feb 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Esketamine

Drug: esketamine hydrochloride

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00847418
    Other Study ID Numbers:
    • EKBB 351/08, 2009DR1015
    First Posted:
    Feb 19, 2009
    Last Update Posted:
    Dec 2, 2010
    Last Verified:
    Dec 1, 2010
    Keywords provided by , ,
    pharmacokinetics
    ketamine
    Anesthetics, Dissociative
    Additional relevant MeSH terms:
    Esketamine

    Study Results

    No Results Posted as of Dec 2, 2010