Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: intranasal ketamine

• Registration Number: NCT00520169
• Lead Sponsor: Javelin Pharmaceuticals

Brief Summary

This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Detailed Description

To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-23
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-09
• Last Update Posted: 2008-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Healthy adults

Exclusion Criteria

• under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	intranasal ketamine	intravenous ketamine
B	intranasal ketamine	intranasal ketamine
A	intranasal ketamine	oral ketamine

Primary Outcome Measures

Name	Time	Method
ketamine pharmacokinetics	multiple

Trial Locations

Locations (1)

Javelin Pharmaceuticals; 🇺🇸 Cambridge, Massachusetts, United States