Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine
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ClinicalTrials.gov Identifier: NCT00520169 |
Recruitment Status :
Completed
First Posted : August 23, 2007
Last Update Posted : January 10, 2008
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Sponsor:
Javelin Pharmaceuticals
Information provided by:
Javelin Pharmaceuticals
Tracking Information | ||||
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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 |
ketamine pharmacokinetics [ Time Frame: multiple ] | |||
Original Primary Outcome Measures ICMJE |
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 |
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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.
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |