Multiple Dose Pharmacokinetics of Intranasal Ketamine

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: intranasal ketamine

• Registration Number: NCT00519987
• Lead Sponsor: Javelin Pharmaceuticals

Brief Summary

This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Detailed Description

To examine safety and characterize the repeat dosing plasma profile, effect on absorption, and accumulation following repeated administration of 30 mg doses of PMI-150 (intranasal ketamine) to healthy adult volunteers.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-23
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-09
• Last Update Posted: 2008-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy adults

Exclusion Criteria

• under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment A	intranasal ketamine	intranasal ketamine

Primary Outcome Measures

Name	Time	Method
pharmacokinetics	multiple