To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine...
Date First Received: April 16, 2008
Last Updated: April 21, 2008
Verified by: Javelin Pharmaceuticals, April 2008
Clinical Trial Phase: Phase 1 | Start Date: November 2007
Overall Status: Completed
Estimated Enrollment: 18
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”
Condition Keyword(s):
Intervention(s):
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: Other, Open Label, Single Group Assignment, Pharmacokinetics Study
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
- Time Frame: 15 days
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 Sponsor Information
Lead Sponsor: Javelin Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Javelin Pharmaceuticals, Inc Study Director Javelin Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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
Clinical Trials Authorship and Review
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