MedDataX Logo

Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

NCT ID: NCT00847418

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pharmacokinetics ketamine Anesthetics, Dissociative

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Esketamine

Group Type EXPERIMENTAL

esketamine hydrochloride

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

esketamine hydrochloride

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hospital Pharmacy, University Hospital Basel, Switzerland.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manuel Haschke, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology and Toxicology, University Hospital Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Research Center, University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EKBB 351/08, 2009DR1015

Identifier Type: -

Identifier Source: org_study_id