Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Javelin Pharmaceuticals.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Javelin Pharmaceuticals
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00520104
First received: August 21, 2007
Last updated: February 27, 2008
Last verified: August 2007
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 21, 2007 | ||||
| Last Updated Date | February 27, 2008 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pharmacokinetics [ Time Frame: multiple ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Pharmacokinetics | ||||
| Change History | Complete list of historical versions of study NCT00520104 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Pharmacokinetics | ||||
| Intervention ICMJE | Drug: intranasal ketamine
drug interaction |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | March 2008 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00520104 | ||||
| Other Study ID Numbers ICMJE | KET-PK-008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Javelin Pharmaceuticals | ||||
| Study Sponsor ICMJE | Javelin Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Javelin Pharmaceuticals | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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