Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

Brief Summary

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

Intervention / Treatment

  • esketamine hydrochloride (DRUG)
    N/A

Condition or Disease

  • Pain

Phase

Study Design

Study type: INTERVENTIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years to 45 Years
Funded by: Other

Masking

Clinical Trial Dates

Start date: Feb 01, 2009
Primary Completion: Aug 31, 2020
Completion Date: Oct 01, 2009 ACTUAL
Study First Posted: Feb 19, 2009 ESTIMATED
Results First Posted: Aug 31, 2020
Last Updated: Dec 01, 2010

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: Male
Minimum Age: 18
Maximum Age: 45
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

More Details

NCT Number: NCT00847418
Other IDs: EKBB 351/08, 2009DR1015
Study URL: https://clinicaltrials.gov/study/NCT00847418
Last updated: Sep 29, 2023