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Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

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ClinicalTrials.gov Identifier: NCT00520104
Recruitment Status : Unknown
Verified August 2007 by Javelin Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : August 23, 2007
Last Update Posted : February 29, 2008
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Pharmacokinetics Drug: intranasal ketamine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Study Start Date : August 2007
Actual Primary Completion Date : February 2008
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: multiple ]


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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

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

Responsible Party: Javelin Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00520104     History of Changes
Other Study ID Numbers: KET-PK-008
First Posted: August 23, 2007    Key Record Dates
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