This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Javelin Pharmaceuticals Identifier:
First received: April 16, 2008
Last updated: April 21, 2008
Last verified: April 2008
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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: 15 days ]

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

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy adults
  • nonsmoker
  • no drug use

Exclusion Criteria:

  • nasal abnormalities
  • airway abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00662883

United States, Maryland
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Javelin Pharmaceuticals
Study Director: Javelin Pharmaceuticals, Inc Javelin Pharmaceuticals
  More Information

Responsible Party: Javelin Pharmaceuticals, Inc. Identifier: NCT00662883     History of Changes
Other Study ID Numbers: KET-PK-009
Study First Received: April 16, 2008
Last Updated: April 21, 2008

Keywords provided by Javelin Pharmaceuticals:
phase I
Healthy volunteers

Additional relevant MeSH terms:
Mometasone Furoate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on August 18, 2017