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

Verified by: Javelin Pharmaceuticals, April 2008
First Received: April 16, 2008 | Last Updated: April 21, 2008 | Phase: Phase 1 | Start Date: November 2007
Overall Status: Completed | Estimated Enrollment: 18
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To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine...

Brief Summary

Official Title: “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”

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

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
  • Study Primary Completion Date: February 2008

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
    • PMI-150 (intranasal ketamine HCl), day 1 mometasone furoate, days 2-15 PMI-150 (intranasal ketamine HCl), day 15

Outcome Measures for this Clinical Trial

Primary Measures

  • Pharmacokinetic parameters
    • Time Frame: 15 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • healthy adults
  • nonsmoker
  • no drug use

Exclusion Criteria:

  • nasal abnormalities
  • airway abnormalities

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Javelin Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Javelin Pharmaceuticals, Inc Study Director Javelin Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662883

Study ID Number: KET-PK-009

ClinicalTrials.gov Identifier: NCT00662883

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00662883