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Sponsored by: |
Javelin Pharmaceuticals |
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Information provided by: | Javelin Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00662883 |
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Pharmacokinetics Study |
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 |
Enrollment: | 18 |
Study Start Date: | November 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
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Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Javelin Pharmaceuticals, Inc. ( Javelin Pharmaceuticals, Inc. ) |
Study ID Numbers: | KET-PK-009 |
Study First Received: | April 16, 2008 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00662883 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ketamine corticosteroid intranasal phase I Healthy volunteers |
Anti-Inflammatory Agents Anesthetics, Intravenous Excitatory Amino Acids Neurotransmitter Agents Mometasone furoate Anesthetics Central Nervous System Depressants |
Healthy Anti-Allergic Agents Anesthetics, Dissociative Anesthetics, General Ketamine Analgesics Peripheral Nervous System Agents |
Anti-Inflammatory Agents Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Mometasone furoate Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Anti-Allergic Agents |
Anesthetics, Dissociative Pharmacologic Actions Sensory System Agents Anesthetics, General Therapeutic Uses Ketamine Peripheral Nervous System Agents Analgesics Central Nervous System Agents Excitatory Amino Acid Antagonists |