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Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Javelin Pharmaceuticals.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520104
First Posted: August 23, 2007
Last Update Posted: February 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Javelin Pharmaceuticals
  Purpose
This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.

Condition Intervention Phase
Pharmacokinetics Drug: intranasal ketamine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications 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:
  • Pharmacokinetics [ Time Frame: multiple ]

Estimated Enrollment: 48
Study Start Date: August 2007
Estimated Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
intranasal ketamine
Drug: intranasal ketamine
drug interaction
Experimental: B
oxymetazoline plus intranasal ketamine
Drug: intranasal ketamine
drug interaction
Experimental: C
intranasal steroid plus intranasal ketamine
Drug: intranasal ketamine
drug interaction

Detailed Description:
To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults
  • Patients with Allergic Rhinitis

Exclusion Criteria:

  • Under age 18
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520104


Locations
United States, Massachusetts
Javelin Pharmaceuticals
Cambridge, Massachusetts, United States, 02140
Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
  More Information

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00520104     History of Changes
Other Study ID Numbers: KET-PK-008
First Submitted: August 21, 2007
First Posted: August 23, 2007
Last Update Posted: February 29, 2008
Last Verified: August 2007

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action