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Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

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.
 
ClinicalTrials.gov Identifier: NCT00520169
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : January 10, 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 January 10, 2008
Study Start Date  ICMJE July 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2008)
ketamine pharmacokinetics [ Time Frame: multiple ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2007)
ketamine 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 Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine
Official Title  ICMJE A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers
Brief Summary This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.
Detailed Description To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: intranasal ketamine
A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.
Study Arms  ICMJE
  • Active Comparator: A
    oral ketamine
    Intervention: Drug: intranasal ketamine
  • Experimental: B
    intranasal ketamine
    Intervention: Drug: intranasal ketamine
  • Active Comparator: C
    intravenous 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 Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2007)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • under 18 years
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 NCT00520169
Other Study ID Numbers  ICMJE KET-PK-007
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 January 2008

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