- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00847418
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
December 1, 2010 updated by: University Hospital, Basel, Switzerland
The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
BS
-
Basel, BS, Switzerland, 4031
- Clinical Research Center, University Hospital Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Esketamine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Manuel Haschke, MD, Clinical Pharmacology and Toxicology, University Hospital Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
February 18, 2009
First Submitted That Met QC Criteria
February 18, 2009
First Posted (ESTIMATE)
February 19, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 2, 2010
Last Update Submitted That Met QC Criteria
December 1, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKBB 351/08, 2009DR1015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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