Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

Phase 1

• Conditions: Pharmacokinetics
• Interventions: Drug: intranasal ketamine

• Registration Number: NCT00520104
• Lead Sponsor: Javelin Pharmaceuticals

Brief Summary

This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.

Detailed Description

To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-23
• Primary Completion: 2008-02
• Last Update Submitted: 2008-02-27
• Last Update Posted: 2008-02-29
• Study Completion: 2008-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Healthy adults
• Patients with Allergic Rhinitis

Exclusion Criteria

• Under age 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	intranasal ketamine	oxymetazoline plus intranasal ketamine
A	intranasal ketamine	intranasal ketamine
C	intranasal ketamine	intranasal steroid plus intranasal ketamine

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	multiple

Trial Locations

Locations (1)

Javelin Pharmaceuticals; 🇺🇸 Cambridge, Massachusetts, United States