Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)
Information source: Javelin Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: PMI-150 (intranasal ketamine HCl); mometasone furoate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Javelin Pharmaceuticals Official(s) and/or principal investigator(s): Javelin Pharmaceuticals, Inc, Study Director, Affiliation: Javelin Pharmaceuticals
Summary
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal
absorption of PMI-150 (intranasal ketamine HCl)
Clinical Details
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
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Pharmacokinetic parameters
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy adults
- nonsmoker
- no drug use
Exclusion Criteria:
- nasal abnormalities
- airway abnormalities
Locations and Contacts
Baltimore, Maryland 21225, United States
Additional Information
Starting date: November 2007
Last updated: April 21, 2008
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