NCT00662883

Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)

A Randomized, Open Label Study to Assess the Effects of a Nasal Corticosteroid on the Pharmacokinetics, Safety, and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Javelin Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Detailed description

Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PMI-150 (intranasal ketamine HCl); mometasone furoate	* 1 dose PMI-150 (intranasal ketamine HCl); day 1 * mometasone furoate, daily; days 2-15 * 1 dose PMI-150 (intranasal ketamine HCl); day 15

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-04-21
• Last updated: 2008-04-22

Locations

1 site across 1 country: United States