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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

Tracking Information
First Submitted Date  ICMJE August 21, 2007
First Posted Date  ICMJE August 23, 2007
Last Update Posted Date February 29, 2008
Study Start Date  ICMJE August 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2008)
Pharmacokinetics [ Time Frame: multiple ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2007)
Pharmacokinetics
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE Drug: intranasal ketamine
drug interaction
Study Arms  ICMJE
  • Experimental: A
    intranasal ketamine
    Intervention: Drug: intranasal ketamine
  • Experimental: B
    oxymetazoline plus intranasal ketamine
    Intervention: Drug: intranasal ketamine
  • Experimental: C
    intranasal steroid plus intranasal ketamine
    Intervention: Drug: intranasal ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 21, 2007)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults
  • Patients with Allergic Rhinitis

Exclusion Criteria:

  • Under age 18
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00520104
Other Study ID Numbers  ICMJE KET-PK-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javelin Pharmaceuticals
Study Sponsor  ICMJE Javelin Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
PRS Account Javelin Pharmaceuticals
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP