Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

Pain Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847418
• Other study ID #: EKBB 351/08, 2009DR1015
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2009
• Last updated: December 1, 2010
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2010
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• esketamine hydrochloride

Locations

Country	Name	City	State
Switzerland	Clinical Research Center, University Hospital Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland,